Identity
- Device Name
- Trocar-Standard EUDAMED
- Model / Reference
- B2001 EUDAMEDNone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972948702319 EUDAMED
- Basic UDI-DI
- 697294870B2001C5 EUDAMED
- EMDN Code
- L031202 ABDOMINAL TROCAR, 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
Trocar-Standard 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 | 697294870B2001C5 | 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 92a67b73-e337-4ec2-b65c-360c3b68af20 61 fields · synced Jun 19, 2026