Identity
- Trade Name
- Needle Driver EUDAMED
- Device Name
- Needle Driver EUDAMED
- Model / Reference
- SP3-ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070996031 EUDAMED
- Basic UDI-DI
- 697507099ND001GU EUDAMED
- Direct Marketing DI
- 06975070996031 EUDAMED
- EMDN Code
- L1205 LAPAROSCOPIC AND THORACOSCOPIC SURGERY NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa 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
Needle Driver by Shenzhen Edge Medical Co., Ltd. — Class IIa — 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 | 697507099ND001GU | Class IIa | 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 874ce457-4be3-4d9c-ad2c-b1efae23e8a6 61 fields · synced Jun 18, 2026