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Disposable Endoscopic Trocars
EUDAMEDClass IIa (EU MDR)
Ref 1003SDModel TCSC-10-3
Identity
- Trade Name
- Disposable Endoscopic Trocars EUDAMED
- Device Name
- Disposable Endoscopic Trocars EUDAMED
- Model / Reference
- TCSC-10-3 EUDAMED1003SD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767871995 EUDAMED
- Basic UDI-DI
- B-06971767871995 EUDAMED
- EMDN Code
- K01010180 TROCAR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Endoscopic Trocars by Wuxi Beien Surgery Device Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971767871995 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wuxi Beien Surgery Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000017684
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 290a46aa-bd0a-487e-8291-75ee7f8115f9 61 fields · synced Jun 18, 2026