Identity
- Trade Name
- Maryland Bipolar Forceps EUDAMED
- Device Name
- Active Forceps EUDAMED
- Model / Reference
- SP3-BM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070995997 EUDAMED
- Basic UDI-DI
- 697507099MBF01KC EUDAMED
- Direct Marketing DI
- 06975070995997 EUDAMED
- EMDN Code
- L1304 ROBOTIC SURGERY FORCEPS AND GRASPERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Maryland Bipolar Forceps 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 | 697507099MBF01KC | 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 b23a1080-4864-43df-81bc-e53123bf4755 61 fields · synced Jun 20, 2026