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Major Notified Bodies

In the United States:

British Standards Institute (BSI)

Contact: Paul C Brooks
Assistant Vice President
BSI
12110 Sunset Hills Road, Suite 200
Reston, VA 20190-3231
USA
Direct Tel: +1-703-464-1923
Cell Phone: +1-571-216-9071
Switchboard: +1-703-437-9000
Fax: +1-703-437-9001

KEMA-Quality

4377 County Line Road
Chalfont, PA 18914
Eastern Region/Headquarters
tel: 215-997-3815
fax: 215-997-9736
email: pmurphy@kemamedical.com
Contact: Patricia L. Murphy
Western Region
3744 Mt. Diablo Blvd., Suite 305
Lafayette, CA 94549
tel: 925-283-7559
fax: 925-283-7555
Contact: Jeff Schakenraad, Ph.D

NSAI (National Standards Authority of Ireland)

Western Region, USA
39159 Paseo Padre Parkway, Suite 232
Fremont, CA 94538
tel: 510-713-0292
fax: 510-713-0294

Eastern Region, USA

402 Amherst Street
Nashua, NH 03063
Phone: 603-228-4412
FAX: 603-882-1985
Judy.Delude@NSAIINC.com
http://www.nsaiinc.com/

TÜV Product Service

Contact: Carole Stamp
Director, Medical Division - North America
1775 Old Highway 8
New Brighton, MN 55112-1891
tel: 612-638-0294
fax: 612-638-0285

 

Outside the United States:

Denmark

DGM - Danish Medical Devices Certification (0543)
Kollegievel 6
DK - 2920 Charlottenlund
Contact: Mr. Poul Schmidt-Andersen, Mr. Morten Nielsen
tel: 45-39-966-400
fax: 45-39-966-401
e-mail: dgm@ds.dk

Greece

ELOT (applied)
Hellenic Organization for Standardization
Acharnon 313
GR-1145 Athens
GREECE
tel: 30-1-201-5025
fax: 30-1-202-5917

Finland

VTT Automation (0537)
Medical Device Technology
PO Box 13052
Hermiankatu 8D
FIN-33101 Tampere Contact: Mr. Kaarle Kylmälä
tel: 358-3-316-3320
fax: 358-3-316-3365

France

G-Med (0459)
33, avenue du Général Leclerc
F-92260 Fontenay aux Roses
tel: 33-1-4095-6354
fax: 33-1-4095-6243
Contact: Mr. Michel Binard

TÜV Product Service (0123)

77 Avenue des Gobelins
F-75013 Paris
tel: 33-1-4408-6770
fax: 33-1-4217-0797
Contact: Mr. Denys Durand-Viel

Germany

RW TÜV Anlagentechnik GmbH (0044)
Institut für Produkterprobung und Werkstofftechnik
Langemarckstr 20
D-45141 Essen
tel: 49-201-825-3455
fax: 49-201-825-3209
Contact: Mr. Bodo Mestmacher

DQS - German Asso. for Certification of Quality (0297)

August-Schanze-Strasse 1A
D-60433 Frankfurt/Main
tel: 49-69-954-270
fax: 49-69-9542-7111
Contact: Dr. Barbara Moos

TÜV Südwestdeutschland e.V (0047)

TÜV CERT - Zertifizierungsstelle
Dudenstrasse 28
D-68167 Mannheim
tel: 49-621-395-367
fax: 49-621-395-604
Contact: Mr. W. Vetten Philipp, Mrs. Ina Plum, Mr. Klaus Gohike

TÜV Cert. (0298)


Reuterstrasse 161
D-53113 Bonn
tel: 49-228-201-220
fax: 49-228-201-2220
Contact: Dr. P. Hermann

Bayersiches Landesamt für Mass und Gewicht (0104)


Franz-Schrank Strasse 9
D-80638 München
tel: 49-89-179-010
fax: 49-89-1790-1336
Contact: Mr. Dietmar Breuer

VDE - Verband Deutscher Elektrotechniker e.V (0366)

Testing and Certification Institute
Merianstrasse 28
D-63069 Offenbach-Main
tel: 49-69-830-6436
fax: 49-69-830-6666
Contact: Mr. Paul Unruh

Landesamt für Mess- und Eichwesen Thüringen (0118)

Unterpörlitzer Strasse 2
D-98693 Ilmenau
tel: 49-3677-531
fax: 49-3677-629-25
Contact: Dr. Klaus-Dieter Somner

ECM - Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH (0481)

 Eifelstrasse 1C
D-52068 Aachen
tel: 49-241-501-034
fax: 49-241-501-038
Contact: Dr. Jutta Vestring, Dr. M. Herold

Ireland

NSAI (0050)
National Standards Authority of Ireland
Certification Services
Glasnevin
IRL-Dublin 9
Contact: Mr. Brian Cunningham, Mrs. Marie O'Connell, Mrs. Chrissie Keane
tel: 353-1-807-3800
fax: 353-1-807-3844
(also see U.S. contact information)

Italy

ISTISAN - Instituto Superiore di Sanità (0373)
Lab. Ingegneria Biomedica
Viale Regina Elena 299
I-00161 Roma
Contact: Professor Sargentin
i tel: 39-6-449-01
fax: 39-6-446-9938

IMQ - Instituto Italiano del Marchio di Qualità (0051)

Italian Quality Mark Institute
Via Quintiliano 43
I-20138 Milano
Contact: Mr. Vincent Formisano
tel: 39-2-507-3296
fax: 39-2-507-3271

Instituto di Certificazione della Qualità

(CERTICHIM) (0546)
Via G Giardino 4
I-20123 Milano
Contact: Mr. Federico Ciampelli
tel: 39-2-8646-5271
fax: 39-2-8646-5295

Luxembourg

Service de l'Energie de l'Etat Luxembourgeois (0499)
BP 10
L-2010 Luxembourg
tel: 352-469-746
fax: 352-222-524

The Netherlands

Stichting
TNO Certification (0336)
Laan Van Westenenk 501
Postbus 541
NL-7300 AM Apeldoorn
tel: 31-55-549-3468
fax: 31-55-549-3288 <:ORMA>

TNO Prevention and Health (0345)

Centrum voor Medische Technologie van het Instituut voor
Verouderings-en Vaatziektenonderzoek
Zernikedreef 9
PO Box 2215
NL-2301 CE Leiden
tel: 31-71-518-1206
fax: 31-71-518-1902

KEMA NV (KEMA Medical) (0344)

Utrechtseweg 310
NL-6812 AR Arnhem
Postbus 5185
NL-6812 ED Arnhem
Contacts: Mr. Peter N. Ruys, Mr. Jan van Lochen
tel: 31-263-562-009
fax: 31-263-525-800

Portugal

INSA - Instituto Nacional de Saude (0323)
Av. Padre Cruz
P-1699 Lisboa Codex
Contact: Mr. Antonio Faria Gomes
tel: 351-1-757-3557
fax: 351-1-757-3671

INFARMED (0503)

Instituto Nacional Da Farmacia E do Medicamento
Parque da Saude de Lisboa
Pavihão 21A
Avenue do Brasil, 53
P-1700 Lisboa
Contact: Mrs. Isabel Abreu
tel: 351-1-795-7836
fax: 351-1-795-7841

Instituto Português da Qualidade (applied)

Ministerio da Industria e Energia
Rua C à Avenida dos Três Vales
P-2825 Monte Da Caparica
tel: 351-1-294-8100
fax: 351-1-294-8101


 

Norway

NIOM (0510)
Nordisk Institutt for Odontologisk
Materialprovning (Scandinavian Institute for Dental Materials)
Kirkeveien 71 B, PO Box 70
N-1344 Haslum
Contact: Dr. Arne Hensten-Pettersen, Dr. Gudbrand Oilo, Dr. Roy I. Holland
tel: 47-67-512-200
fax: 47-67-591-530

NEMKO (0470)

PO Box 73
Blindern
N-0314 Oslo
Contact: Mr. Jan Erik Pettersen, Mr. Frank Skarspsno
tel: 47-22-960-330
fax: 47-22-960-550

Det Norske Veritas Region Norge AS (0434)

PO Box 300
N-1322 Hovik
tel: 47-67-577-250
fax: 47-67-577-474

Spain

Ministerio de Sanidad y Consumo (0318)
Direccion General de Farmacia y Productos Sanitarios
Subdireccion General de Productos Sanitarios
Paseo del Prado 18-20
E-28014 Madrid
Contact: Mrs. Carmen Abad Luna, Mrs. Celia Sanchez
tel: 34-1-596-4347 / 596-4022
fax: 34-1-596-4400

Sweden

SEMKO AB MedTech (0413)
PO Box 1103
S-164 22 Kista
Contact: Mr. Nils Bromander
tel: 46-8-750-0000
fax: 46-8-750-6030

UK

Lloyds Register Quality Assurance Ltd.
Contact: Ms. Pauline Hylton, EC Directives Manager
Norfolk House, Wellesley Road
Croydon CR9 2DT
UNITED KINGDOM
tel: 44-81-688-6883
fax: 44-81-681-8146

UL International (UK) Ltd.

Contact: Steven Buxton
Wonersh House
The Guildway
Old Portsmouth Road
Guildford, Surrey GU3 1LR
UK
Telephone: +44 (0) 1483 302 130
Fax: +44 (0) 1483 302 230