SteriLance Medical (Suzhou) Inc. No. 68 Litanghe Road
(see attachment for products included)
Replaces Approval, Registration No.: HD 60108235 0001
- Disposable Blood Lancets
- Disposable Safety Lancets
- Disposable Scalpels and Cartridges
- Disposable Surgical Blades
- Disposable Insulin Pen Needles
Aspects of manufacture concerned with securing
and maintaining sterile conditions:
- Disposable Swabs
Vollst. QMS, Anhang II MDD
EC declaration of conformity (Full quality assurance system) Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices
The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.
The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.
This approval can be used by the company in line with the declaration of conformity.