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Optical Trocar
EUDAMEDClass IIa (EU MDR)
Ref TRO-12VM2Model TR/TRO/TRC/TRE/TRA Series
Identity
- Trade Name
- Optical Trocar EUDAMED
- Device Name
- Trocar EUDAMED
- Model / Reference
- TR/TRO/TRC/TRE/TRA Series EUDAMEDTRO-12VM2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123021434 EUDAMED
- Basic UDI-DI
- 471412302TR-01XQ EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, 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
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
Optical Trocar by Lagis Enterprise 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 | 471412302TR-01XQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7faa206a-6707-4776-b72c-4d8596cc9301 61 fields · synced Jun 20, 2026