Identity
- Trade Name
- burn dressing EUDAMED
- Device Name
- Sterile dressing sheet EUDAMED
- Model / Reference
- 600*800 EUDAMED60*80cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974567461557 EUDAMED06974567461816 EUDAMED
- Basic UDI-DI
- 697456746000105V EUDAMED
- Direct Marketing DI
- 06974567461557 EUDAMED06974567461816 EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMEDM030102 NON-WOVEN BANDAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDGermany 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
burn dressing 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 | 697456746000105V | 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 (2)
- EUDAMED a5ef4214-c80c-47df-99fd-eed53f162b9c 61 fields · synced Oct 7, 2026
- EUDAMED 8754dbf5-290a-48fa-9242-c3bd75241f5e 61 fields · synced May 17, 2026