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Disposable Trocars
EUDAMEDClass IIa (EU MDR)
Ref F01105Ref F01001Ref F01002Ref F01104Ref F01101Ref F01003Ref F01102
Identity
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- F01105 EUDAMEDF01001 EUDAMEDF01002 EUDAMEDF01104 EUDAMEDF01101 EUDAMEDF01003 EUDAMEDF01102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937893901012 EUDAMED06937893900312 EUDAMED06937893900329 EUDAMED06937893900404 EUDAMED06937893900374 EUDAMED06937893900336 EUDAMED06937893900381 EUDAMED
- Basic UDI-DI
- 69378939F015U EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDPoland EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Disposable Trocars by Tonglu Qianyan Medtech 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 | 69378939F015U | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tonglu Qianyan Medtech Co., Ltd
- EUDAMED SRN
- CN-MF-000017342
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (7)
- EUDAMED ebfa8522-7f6b-4424-9e24-2deb57f10b50 61 fields · synced Jul 31, 2026
- EUDAMED 688ab298-250f-4200-821a-ad39f8bf1d37 61 fields · synced May 17, 2026
- EUDAMED 3e5fb2fe-27da-454d-be84-7f61b16f91c5 61 fields · synced May 17, 2026
- EUDAMED 7a0bcc5d-9000-492b-a0ad-d91bb13b2a43 61 fields · synced May 18, 2026
- EUDAMED b342fadf-e142-4b21-bab7-a9ed33a6f1e0 61 fields · synced May 18, 2026
- EUDAMED ec3d0a9a-fd87-4ef4-9827-0261d7f869ae 61 fields · synced May 18, 2026
- EUDAMED 08f10221-3498-42ac-9610-9959fea59f1f 61 fields · synced May 19, 2026