Identity
- Trade Name
- wound plaster EUDAMED
- Device Name
- Sterile wound plaster EUDAMED
- Model / Reference
- SH-3101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974567460260 EUDAMED
- Basic UDI-DI
- 697456746000115X EUDAMED
- Direct Marketing DI
- 06974567460260 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
wound plaster by Danyang Sunmed Healthcare Corporation — 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 | 697456746000115X | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Sunmed Healthcare Corporation
- EUDAMED SRN
- CN-MF-000013734
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 213047b8-96cd-4a0d-94d8-612749a799dd 61 fields · synced Jun 18, 2026