0120 - NOTIFIED BODY (UNDER DIRECTIVE 93/42/EEC Medical devices)

Name and address of the notified bodie
Responsible for the following products
Responsable for the following procedures/modules
Annexes/articles of the directives

SGS YARSLEY INTERNATIONAL CERTIFICATION SERVICES LDT

Unit 202B, Worle Parkway
Weston-Super-Mare
UK-Somerset BS22 0WA

T : 00 44 193 4522917
F : 00 44 193 4522137
URL :
Email :

All medical devices :

  • Comdoms (with and without spermicide),
  • Defibrillators (external),
  • Dialysis Equipment,
  • ECG Monitors,
  • Infusion Pumps,
  • Clinical Thermometers.

Active Medical Devices :

  • (class I measuring) and IIa which require compliance with EN 60601-1 and measurements of voltage, current, temperature, pressure, weight and time.

Full quality assurance
Type - examination
EC verification
Production quality assurance
Product quality assurance

Annex II
Annex III
Annex IV
Annex V
Annex VI
 


site - http://www.hosmat.fr - dernière mise à jour : 6 novembre 1999