Identity
- Trade Name
- Einweg-Abdeckfolie EUDAMED
- Device Name
- Disposable Drape EUDAMED
- Model / Reference
- DR1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942854300704 EUDAMED
- Basic UDI-DI
- 697507099DD000DC EUDAMED
- Unit of Use DI
- 06942854300711 EUDAMED
- EMDN Code
- K01020299 ROBOTIC SURGERY INSTRUMENT, SINGLE-USE - OTHER 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
Einweg-Abdeckfolie by Shenzhen Edge 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 | 697507099DD000DC | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Edge Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039045
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 011b493a-c7df-4378-8412-cda00e874821 61 fields · synced Jun 19, 2026