Identity
- Trade Name
- Sterile Wound Dressing EUDAMED
- Device Name
- Sterile Wound Dressing EUDAMED
- Model / Reference
- Type W02 EUDAMEDW0260100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489891316 EUDAMED
- Basic UDI-DI
- 697548989XLW025A EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Wound Dressing by Shandong Shinrise Medical Supplies Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697548989XLW025A | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Shinrise Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031315
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 07b2522f-38a9-464b-b9c8-8e0faea65e3a 61 fields · synced Oct 6, 2026