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Double Fenestrated Grasper
EUDAMEDClass IIa (EU MDR)
Ref NoneModel 0201Model 200189
Identity
- Device Name
- Double Fenestrated Grasper EUDAMED
- Model / Reference
- 0201 EUDAMEDNone EUDAMED200189 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972948701032 EUDAMED06972948701889 EUDAMED
- Basic UDI-DI
- 697294870DFGF1000ZJ EUDAMED697294870200189YG EUDAMED
- Direct Marketing DI
- 06972948701032 EUDAMED06972948701889 EUDAMED
- EMDN Code
- L1304 ROBOTIC SURGERY FORCEPS AND GRASPERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDPoland 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 (2)
- EUDAMED 3325f265-43db-4e80-a7b5-058d7d645573 61 fields · synced Jul 12, 2026
- EUDAMED fd165648-3c5b-493e-98b7-48093f85861b 61 fields · synced May 19, 2026