Identity
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- F01403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937893900947 EUDAMED
- Basic UDI-DI
- 69378939F015U EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 (1)
- EUDAMED 96825713-2220-4d06-9cdb-b29e2a2666e1 61 fields · synced Jun 18, 2026