Pure Global

Sterile Wound Dressing - EUDAMED Registration 06975489891712

Access comprehensive regulatory information for Sterile Wound Dressing in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06975489891712 and manufactured by Shandong Shinrise Medical Supplies Co., Ltd. in China.

This page provides complete registration details including trade name (Sterile Wound Dressing), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
06975489891712
No
Sterile Wound Dressing
Trade Name: Sterile Wound Dressing
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M04010102
Trade Name
Sterile Wound Dressing
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975489891712
Basic UDI
697548989XLW045E
Version Date
March 05, 2025
Manufacturer Last Update
February 18, 2025
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.56 Zhangbei Road 256410 Zibo
Email
shinrise@shinrisemedical.com
Authorized Representative
SRN
DE-AR-000005081
Country
Germany
Address
5 Kennedydamm Dรผsseldorf
Email
info@eunitor.de
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
United Kingdom (Northern Ireland only)
Device Characteristics
Human Tissues
No
Animal Tissues
No