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Balloon Trocar
EUDAMEDClass IIa (EU MDR)
Ref TRS-12VX1Model TRB/TRS SeriesRef TRB-12V1
Identity
- Trade Name
- Balloon Trocar EUDAMED
- Device Name
- Balloon Trocar EUDAMED
- Model / Reference
- TRB/TRS Series EUDAMEDTRS-12VX1 EUDAMEDTRB-12V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123024565 EUDAMED04714123024534 EUDAMED
- Basic UDI-DI
- 471412302TRB-01XT 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
Balloon 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 | 471412302TRB-01XT | 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 (2)
- EUDAMED 740d5ae3-65a6-4c8f-b1fd-afea356fff38 61 fields · synced Jul 26, 2026
- EUDAMED b1650b38-2e77-415c-8d38-96f87c0577fc 61 fields · synced May 18, 2026