Identity
- Device Name
- Double Fenestrated Grasper EUDAMED
- Model / Reference
- 0201 EUDAMEDNone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972948701039 EUDAMED
- Basic UDI-DI
- 697294870DFGF1000ZJ EUDAMED
- EMDN Code
- L1304 ROBOTIC SURGERY FORCEPS AND GRASPERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Double Fenestrated Grasper by Suzhou Kangduo Robot 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 | 697294870DFGF1000ZJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Kangduo Robot Co., Ltd.
- EUDAMED SRN
- CN-MF-000033401
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 4238672b-2f14-4396-acf7-bf438c974544 61 fields · synced Jun 18, 2026