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Disposable Trocars
EUDAMEDClass IIa (EU MDR)
Ref OBS-T10-BRef OBS-T10-ARef OBS-T12-CTRef OBS-T12-AT
Identity
- Trade Name
- Disposable Trocars EUDAMED
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- OBS-T10-B EUDAMEDOBS-T10-A EUDAMEDOBS-T12-CT EUDAMEDOBS-T12-AT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411510034 EUDAMED06939411509991 EUDAMED06939411510089 EUDAMED06939411510010 EUDAMED
- Basic UDI-DI
- B-06939411510034 EUDAMEDB-06939411509991 EUDAMEDB-06939411510089 EUDAMEDB-06939411510010 EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 Trocars by Baisheng Medical 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-06939411510034 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED 7b408614-f9b1-45bf-848f-a0fe222ae616 61 fields · synced Oct 6, 2026
- EUDAMED 39067f72-1d7e-43e6-9098-477e67bd13f0 61 fields · synced May 18, 2026
- EUDAMED d9344187-2917-4419-bfc9-72b7d89dd8b8 61 fields · synced May 18, 2026
- EUDAMED 36fb3897-d131-473a-bf60-d7abb79c6689 61 fields · synced May 19, 2026