Identity
- Trade Name
- Film roll EUDAMED
- Device Name
- Medical dressing roll EUDAMED
- Model / Reference
- 220947 EUDAMED220949 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926515402310 EUDAMED06926515402358 EUDAMED
- Basic UDI-DI
- 69593857MDR000001CB EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Film roll by Zhende Medical 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 | 69593857MDR000001CB | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e4ff4591-3f91-4cf8-b106-0e9838c0ef1a 61 fields · synced Jul 29, 2026
- EUDAMED 92653346-57e1-44c4-9fe3-8aa45dcfe4b6 61 fields · synced May 17, 2026