Identity
- Trade Name
- Zange, bipolar EUDAMED
- Device Name
- Active Forceps EUDAMED
- Model / Reference
- MP1305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942854300087 EUDAMED
- Basic UDI-DI
- 697507099MBF00KA EUDAMED
- Direct Marketing DI
- 06942854300087 EUDAMED
- EMDN Code
- L1304 ROBOTIC SURGERY FORCEPS AND GRASPERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Zange, bipolar by Shenzhen Edge Medical Co., Ltd. — Class IIb — 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 | 697507099MBF00KA | Class IIb | 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 e3272c9d-c066-4656-94d1-7714874ad9a1 61 fields · synced Jul 9, 2026