Phone: +1 406 568-2911
Fax: +1 406 568-2307

http://www.quadfive.com

quadfive@quadfive.com

Company Profile

Producer of donor animal blood, sera and plasma
Quad Five is an OEM company that produces sterile donor animal blood, sera and plasma. Four thousand five hundred sheep, horses, cattle and goats provide the foundation for the traceability, consistency and performance of our products. Quad Five is an international supplier to manufacturers of culture media, diagnostic kits and vaccines.

Product Information
03.01.11 Controls / Standards / Calibrators clinical chemistry
Donor Blood Protocol 16.10.2008

The collection and use of animal blood in microbiology dates back to the earliest preparations of culture media. Blood, as a biological fluid, can be affected by different parameters, including the age, genetics, diet, health, and environment of its source.

Quad Five has worked for 20 years to develop and maintain a donor animal program that controls these issues as they relate to the quality and consistency of our blood products.

All Quad Five defibrinated blood and blood products in anticoagulants are produced “just in time” specifically for your order. To provide the highest quality possible, these products are collected and processed within 12-48 hours of shipment. While we do not maintain shelf stock, we typically are able to ship small orders received by 10:00 a.m. the same day.

If you manufacture microbiological culture media, we believe you will find our products to be the best available.

Phone: +31 299 412000
Fax: +31 299 412001

http://www.qservegroup.com

info@qservegroup.com

Company Profile

About Us

Willibrord Driessen founded Qserve Consultancy in 1998. Qserve Consultancy is an independent medical device regulatory consulting firm with an in-house expertise needed to bring medical devices rapidly to the market in Europe and elsewhere. Qserve Consultancy is part of the Qserve Group.

The Qserve Group comprises:

Three divisions, two in Europe and one in the United States:

The Netherlands, Amsterdam:

Qserve Consultancy B.V.

Qserve Support B.V.

The United States, New Hampshire, Claremont:

Qserve America Inc. (A member of the Qserve Group).

Qserve, as Medical Device Consultants, facilitates product market approval of your device, e.g., CE Marking in Europe and FDA approval in the USA, and provides Quality Management System implementation of ISO 13485, auditing conform ISO 13485, as well as (pre)clinical evaluations. We can also be of help with post marketing compliance issues, such as vigilance. Qserve is the expert in quality assurance and regulatory affairs for manufacturers of medical devices.

We have a unique combination of in-house expertise, over a wide range of products, in a variety of regulatory and quality systems for medical devices such as:

Our highly-skilled, technical, regulatory and quality staff in Europe and the US have almost 100 years of experience between them, and includes certified Lead Auditors. Projects are handled with utmost priority and attention to detail. They can be undertaken at our offices or at your own premises. Qserve is proud of the fact that many of our clients return to us for additional advice year on year. Qserve maintains excellent relationships with regulatory authorities, government agencies, testing laboratories and others involved with medical devices.

Through our “ One-Stop-Shopping” program, we are able to offer you a number of turnkey modules which can synchronize your EU and US submissions saving you time and money.

Our challenge is to guide and to manage your company in the most efficient and practical ways to achieve faster product registration and market approval.

Our Philosophy

The core philosophy behind our service and approach is the optimization of practical advice, customized to an individual company’s culture and needs, in the most efficient and cost-effective manner. Achieving optimal acceptance and recognition of your registration and quality management system, accelerates complete market approval.

Product Information
10.02 Further education and training
Our Services 09.10.2008

Qserve Consultancy advises and supports your organization during implementation and with maintenance of your quality management systems, thru to all activities concerning applications for and preservation of registrations world-wide, and/or the required audits, including:

* Due Diligence & GAP Analysis

* Strategic Planning

* CE Marking

* Risk Management (ISO 14971)

* ISO 13485, QSR, CMD/CAS

* Audits

* Biocompatibility & Safety

* Training

* Validation

* (Pre)clinical

* Distributor search

* Authorized Representative, AR

* 510(k), IDE, PMA submissions

* US Agent & Official Correspondent Services

We provide our services to new ventures in the medical devices branch in Europe or the United States, who have a limited knowledge of the EU or FDA regulations, but we are also a valuable partner for medium and large organizations. Our customers benefit from our excellent connections and rapport with the Regulatory Authorities and Notified Bodies in Europe and the US, and from our considerable in-house expertise.

In co-operation with our partner Qserve America, Qserve Consultancy can also offer you the services of an Authorized Representative (AR), US-Agent, and an Official Correspondent.

Should you require further information about these services, please contact us.

10.04 Professional institutions

10.08 Logistic services

10.08.06 Consulting for health organisations

10.10 Technical equipment management, Test houses/Certification Bodies

10.10.02 Certification and testing of medical devices, quality assurance

Phone: +39 059 660209
Fax: +39 059 669387

http://www.pyxis-int.com

crm@pyxis-int.com

Company Figures
Number of employees 1-19
Export content max. 50%
Year of foundation 2003
Area of business Components, Parts, Original Equipment Manufacturers

Design, Research and Development Services

Filtration

Company Profile

CORE ACTIVITIES
Pyxis S.r.l. is engaged in the development, manufacturing and global distribution of innovative “next generation” components and parts for several medical applications, with a special consideration to haemodialysis.

Pyxis S.r.l. is also supporting companies in need of state-of-the art and modelling services through its pioneering Engineering Services Group providing support in CAD service, tool manufacturing, assembly and automation development and process engineering.

Phone: +41 44 2727503
Fax: +41 44 2727501

http://www.pulsonic.ch

info@pulsonic.ch

Company Contacts
Department/ Name Address

PULSONIC AG Tel. +41-(0)44-272 7503, Fax +41-(0)44-272 7501

Company Figures
Area of business Electronical Equipment / Medical Technology

Company Profile

About us
The PULSONIC Company is based in Schlieren/Zurich, Switzerland.
PULSONIC is a leading developer with pioneering experience,
a manufacturer and a distributor of high performance ECG and
stethoscope instruments for heart rhythm monitoring solutions
in human and veterinary medicine.

PULSONIC’s products comply with the quality control norms
EN ISO 9001:2000; EN ISO 13485:2003 and the Medical
Device Directive 93/42 EEC.

Product Information
01.01.02.03 Electrocardiography (ECG) equipment and accessories
SONOPLUS 3000 30.09.2008

Features
Digital cardioscope for human medicine

ECG & stethoscope in one unit

Pocket size and proven professional design

Computer based ECG recording technology

Special comb shaped gold-plated electrodes

High-resolution display of the ECG and heart rate data

Leads I – II -III

Automatic pacemaker detection

Auto scaling of ECG amplitudes

Sampling frequency: 256 Hz

Frequency response: 0.05/0.5 – 40 Hz (-3dB)

Recording speed of 12.5, 25 or 50 mm/s

Data storage (in-unit) up to 16 minutes
and 99 patients records s

SONOPLUS 3000-DS 30.09.2008

Features
Digital cardioscope for human medicine

ECG & stethoscope in one unit

ECG unit detachable from stethoscope tubing

Pocket size and proven professional design

Computer based ECG recording technology

Special comb shaped gold-plated electrodes

High-resolution display of the ECG and heart rate data

Leads I – II -III

Automatic pacemaker detection

Auto scaling of ECG amplitudes

Sampling frequency: 256 Hz

Frequency response: 0.05/0.5 – 40 Hz (-3dB)

Recording speed of 12.5, 25 or 50 mm/s

Data storage (in-unit) up to 16 minutes
and 99 patients records

Phone: +49 89 459914-0
Fax: +49 89 459914-18

http://www.pulsion.com

info@pulsion.com

Company Contacts
Department/ Name Address

Kirstin von Hammerstein Tel: 49-89–459914-200
hammerstein@pulsion.de

Company Figures
Number of employees 50-99
Export content max. 50%
Year of foundation 1990
Area of business Electronical Equipment / Medical Technology

Physiotherapy / Orthopaedic Technology / Occupational Therapy

Language: German Language: English Company Profile

About us:
PULSION consequently became one of the worldwide leading specialists for intelligent medical diagnosis and therapy management systems since its foundation in 1990. With its innovative product lines PULSION was able to constitute a paradigm shift in the field of hemodynamic therapy management in critically ill patients.

In addition to the product lines for hemodynamic management, PULSION offers a number of systems for function and perfusion monitoring of other organs and tissues. The company is transferring its outstanding medical and technological competence into medical product innovations.
The complementary product lines and unique physiologic parameters put PULSION in an extraordinary position in the fast growing market for patient monitoring.

The headquarters of PULSION Medical Systems is in Munich, Germany. Moreover subsidiaries have been built up in England, France, Belgium, Spain, Australia and in the USA.

Product Information
01.01.02.02 Blood flow measurement equipment

01.01.02.02.05 Measuring micro circulation

01.01.02.05 Cardiac catheterisation equipment

01.01.02.05.01 Cardiac output measuring instruments (output per minute or over time/thermodilution)

01.04.04 Patient monitoring systems / Measuring stations

01.04.04.08 Oximeters, oxygen saturation meters

01.04.04.09 Patient monitors

05.11 Catheters

Phone: +64 9 9219335
Fax: +64 9 9219501

http://www.pulsecor.com

info@pulsecor.com

Company Contacts
Department/ Name Address

Enquiries info@pulsecor.com

Company Profile

About us…
Pulsecor develops products that enable non-invasive measurement of arterial health and heart function. Pulsecor’s R6.5 cardiovascular monitor is as portable, quick and easy-to-use as the familiar, trusted, non-invasive blood pressure cuff.

Pulsecor’s technology has been clinically evaluated over seven years and its measures of augmentation index and cardiac performance have been shown to be repeatable, reproducible and sensitive to physiological changes in the doctor’s office and the operating theatre. Pulsecor’s non-invasive central blood pressure measurement (currently under development) is showing accuracy that exceeds the accepted standards for peripheral blood pressure.

Pulsecor’s R6.5 monitor is suitable for research use wherever non-invasive blood pressure cuffs are used. Its speed, accuracy and familiarity make it an excellent choice for clinical studies related to screening, risk profiling, pharmaceutical trials or monitoring physiology.

Pulsecor’s VasomonR software for the PC allows remote-control of the R6.5 monitor and has been designed for complete, easy data management.

Product Information
01.01.02.01 Blood pressure equipment

01.01.02.01.03 Electronic blood pressure manometers and accessories

01.01.02.02 Blood flow measurement equipment

01.01.02.02.09 Pulse oscillographs

Phone: 962-6-4025470-0
Fax: 962-6-4025484-0

http://www.protech.jo

info@protech.jo

Phone: +82 2 5566301
Fax: +82 2 5586301

http://www.prosonic.co.kr

Company Contacts
Department/ Name Address

Sales and Marketing Dept. #712 Kolon Science Vallley 2, 811 Guro-dong, Guro-gu, Seoul, KOREA
frank@prosonic.co.kr

Company Figures
Number of employees 100-499
Sales volume 10-49 Mio US $
Export content max. 50%
Year of foundation 1990
Area of business Electronical Equipment / Medical Technology

Company Profile

True innovator in ultrasound technologies
Prosonic, founded in 1990, is a leading manufacturer of medical ultrasound probes with the world’s biggest probe-only production capacity. We steadfastly live up to our mission by addressing technical challenges with innovative and reliable solutions. Pioneering new applications of medical ultrasound, we provides a wide variety of products that compete with the world class quality. Prosonic is on the cutting edge of ultrasound field through our constant research and development of new technologies.

Product Information
01.02.06 Ultrasound diagnostic equipment

Phone: +33 2 43056895
Fax: +33 2 43057200

Company Contacts
Department/ Name Address

Benoit Paquet Promotal, International Sales & Marketing Director
b.paquet@promotal.fr

Export Sales Department Promotal, Tel : 00 33 243 056 895, Fax : 00 33 243 057 200
sales.export@promotal.fr

François Nogrix Promotal, President
f.nogrix@promotal.fr

Service Commercial France Promotal, Tél : 02 43 05 17 76, Fax : 02 43 05 72 00
commercial.france@promotal.fr

Company Figures
Number of employees 100-499
Export content max. 50%
Year of foundation 1963
Area of business Electronical Equipment / Medical Technology

Language: German Language: English Company Profile

Leading manufacturer in medical furniture
For more than 40 years, Promotal has designed and manufactured a complete range of quality medical equipment that responds to the needs of hospital establishments, specialized centres, retirement homes, GP’s and specialized practitioners. From transfer stretchers to dialysis chairs and examination tables, Promotal offers quality products and services to the healthcare professional.

Product Information
01.03.01 Dialysis equipment

01.03.01.02 Haemodialysis equipment and accessories

01.05.01 Surgery Room Equipment

01.05.01.03 Treatment trolleys

01.05.01.15 Anaestetic trolleys

01.05.02 Medical lighting

01.05.02.01 Medical lamps, examination lamps

01.06.02 Sterilisation and disinfection equipment and accessories / autoclaves

01.06.02.13 Small automated sterilisers for medical practices

01.07.02 Furnishing / Equipment for mobile medical treatment rooms and vehicles

01.07.02.03 Hydraulically adjustable patient trolleys, adjustable-height patient trolleys

01.07.02.04 Stretchers

01.07.02.07 Mobile operation and treatment couches

01.09.02 Ward equipment and apparatus

01.09.02.22 Patient care trolleys

01.09.03 Furnishing / Equipment for examination and treatment rooms, intensive care units and wake up rooms

01.09.03.11 ENT examination and operation chairs

01.09.03.20 Other examination chairs

01.09.03.22 Examination and treatment couches

01.09.03.23 Examination and operation chairs

01.09.03.24 Examination chairs for gynaecology, urology, rectoscopy and cystoscopy

01.09.06 Equipment and apparatus for wards and examinations

01.09.06.01 Treatment chairs/tables

01.10.06 Sanitary installations

01.10.06.03 Shower trolleys, adjustable height, shower cabins for handicapped patients

Phone: +39 081 5585118
Fax: +39 081 2292267

http://www.webpromoitalia.com

events@webpromoitalia.com

Company Figures
Number of employees 50-99
Area of business Electronical Equipment / Medical Technology

Commodities and Consumer Goods for Surgeries and Hospitals

Company Profile

Promoitalia

Promoitalia is a multinational Company leader in the fields of Aesthetics and Aesthetic Medicine.
The Company is divided in three different departments:
Beauty Instruments: specialized in highly technical equipments used for both medical and aesthetic purposes.
Cosmetic Line: specialiazed in Bio-engineered cosmoceutics, fillers and mesococktails.
Medical Device: specialized in the production of tools for plastic, reconstructive and cosmetic surgery.
Promoitalia has branches in several countries and distributors all over the world.
The mission of the Company is to innovate and always find new solutions to establish new trends in this market, more than the 20% of Promoitalia’s yearly turnover is invested in Research and Development, with its own scientific department costantly elaborates new ideas and improves its already succesfull range of products.
25 Products , 32 Countries , One Brand , One Philosophy.

Thanks to the versatility and ability to start new trends, the young, enthusiastic and intuitive management of this Company has created a well-known and prestigious brand with a worldwide presence. Our philosophy :
”Never stop searching for innovative solutions”.
PromoItalia keeps searching persistently and updating its products and technologies.The relentless improvement guarantees our customers quality and safety.
PromoItalia’s products are a guarantee of its uniqueness, created with particular attention to the needs of those who want to slow the march of time, take care of their personal image and body, as well as those who love feeling good, because the awareness of looking good brings one self-esteem and improves one’s quality of life.

Product Information
01.03.03 Implants and protheses

01.03.03.17 Absorbable implants

01.03.04 Infusion technology equipment

01.03.04.14 Infusion devices

01.03.08 Laser therapy equipment

01.03.08.03 Laser pens

01.03.12 Equipment for treatment with gases

01.03.12.02 Dry gas bathing facilities (oxygen, ozone and carbon dioxide dry gas baths)

01.03.14 Ultrasonic Therapy Equipment

01.08.02 Surgical instruments and products

01.08.02.04 Surgical disposable instruments

01.09.01 Lighting systems and equipment

03.03.01 Differential cell counters

04.08 Physiotherapeutic mobility aids

04.08.02 Equipment for stamina training

04.14 Training equipment