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Blunt Tip Trocar
EUDAMEDClass IIa (EU MDR)
Ref TRO-12B1-AHModel TR/TRO/TRC/TRE/TRA SeriesRef TRO-11B1Ref TRO-12B1
Identity
- Trade Name
- Blunt Tip Trocar EUDAMED
- Device Name
- Trocar EUDAMED
- Model / Reference
- TR/TRO/TRC/TRE/TRA Series EUDAMEDTRO-12B1-AH EUDAMEDTRO-11B1 EUDAMEDTRO-12B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123021335 EUDAMED04714123020154 EUDAMED04714123020222 EUDAMED
- Basic UDI-DI
- 471412302TR-01XQ EUDAMED
- EMDN Code
- K01010102 HASSON TROCAR, SINGLE-USE EUDAMEDK01010101 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
Blunt Tip 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 (3)
- EUDAMED ddc96778-83a3-4c8e-9545-ca08d1faba44 61 fields · synced Sep 17, 2026
- EUDAMED ff9037f4-0936-4496-bfdf-cf2d880e6b55 61 fields · synced May 17, 2026
- EUDAMED 27253616-5a50-4a63-bd80-82b439c4f59d 61 fields · synced May 18, 2026