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Universal Trocar Stability Sleeve
EUDAMEDClass IIa (EU MDR)
Ref TRO-12XModel TR/TRO/TRC/TRE/TRA Series
Identity
- Trade Name
- Universal Trocar Stability Sleeve EUDAMED
- Device Name
- Trocar EUDAMED
- Model / Reference
- TR/TRO/TRC/TRE/TRA Series EUDAMEDTRO-12X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123021649 EUDAMED
- Basic UDI-DI
- 471412302TR-01XQ 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
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
Universal Trocar Stability Sleeve 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 f7711b0e-f342-4a0f-8e67-6825fec5494b 61 fields · synced Jun 19, 2026