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Shielded Bladed Trocar
EUDAMEDClass IIa (EU MDR)
Ref TR-06SL1Model TR/TRO/TRC/TRE/TRA SeriesRef TRC-11S1Ref TRC-06S1Ref TRC-06SL2Ref TRC-06SL2-NRef TRC-06S2Ref TRA-06SL2-NRef TRA-06S1-NRef TRO-12S1Ref TR-06S2Ref TRC-06S2-NRef TRO-11S1Ref TRC-12S1Ref TRC-06S1-NRef TRC-11S2Ref TRO-12SX1Ref TRA-06SL1-NRef TRO-11S2Ref TRC-12S2-ARef TRC-11S2-ARef TRC-06SL1-NRef TRO-12S2
Identity
- Trade Name
- Shielded Bladed Trocar EUDAMED
- Device Name
- Trocar EUDAMED
- Model / Reference
- TR/TRO/TRC/TRE/TRA Series EUDAMEDTR-06SL1 EUDAMEDTRC-11S1 EUDAMEDTRC-06S1 EUDAMEDTRC-06SL2 EUDAMEDTRC-06SL2-N EUDAMEDTRC-06S2 EUDAMEDTRA-06SL2-N EUDAMEDTRA-06S1-N EUDAMEDTRO-12S1 EUDAMEDTR-06S2 EUDAMEDTRC-06S2-N EUDAMEDTRO-11S1 EUDAMEDTRC-12S1 EUDAMEDTRC-06S1-N EUDAMEDTRC-11S2 EUDAMEDTRO-12SX1 EUDAMEDTRA-06SL1-N EUDAMEDTRO-11S2 EUDAMEDTRC-12S2-A EUDAMEDTRC-11S2-A EUDAMEDTRC-06SL1-N EUDAMEDTRO-12S2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123020123 EUDAMED04714123029027 EUDAMED04714123022585 EUDAMED04714123023803 EUDAMED04714123023926 EUDAMED04714123023902 EUDAMED04714123024893 EUDAMED04714123024831 EUDAMED04714123020260 EUDAMED04714123020079 EUDAMED04714123023919 EUDAMED04714123020192 EUDAMED04714123022516 EUDAMED04714123022592 EUDAMED04714123023933 EUDAMED04714123020420 EUDAMED04714123024879 EUDAMED04714123020208 EUDAMED04714123024404 EUDAMED04714123024367 EUDAMED04714123023896 EUDAMED04714123020277 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 EUDAMEDPortugal 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
Shielded Bladed 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 (22)
- EUDAMED 620e363a-913b-4c84-b46c-af22c6e98667 61 fields · synced Aug 3, 2026
- EUDAMED da5287aa-7929-4be3-bd15-da38c79b6754 61 fields · synced May 11, 2026
- EUDAMED e80725e5-1152-4da6-b783-53c456709546 61 fields · synced May 16, 2026
- EUDAMED 901ee38e-b2ca-4308-bd78-0deeb06df81b 61 fields · synced May 16, 2026
- EUDAMED 959e6468-2c67-4f74-acd3-78bbd269e947 61 fields · synced May 16, 2026
- EUDAMED c6d1006c-0ab4-4c8f-ac87-98380c537ef7 61 fields · synced May 17, 2026
- EUDAMED e246250c-90fe-49ff-8b1d-286adee54816 61 fields · synced May 17, 2026
- EUDAMED aff51621-28c7-4f94-a77d-fc8d8f4aa669 61 fields · synced May 17, 2026
- EUDAMED 742efbbb-4501-41d1-a163-e83ee8c09ef4 61 fields · synced May 17, 2026
- EUDAMED a9af6088-2dfa-4c34-8b78-a753b20286da 61 fields · synced May 17, 2026
- EUDAMED 3c101dd9-3cbc-48b4-a3c8-84d81953bd72 61 fields · synced May 18, 2026
- EUDAMED f370cbc7-e278-4c3b-87e5-3ff38f852649 61 fields · synced May 18, 2026
- EUDAMED cd5c716c-939d-43c8-b700-06f391d1a401 61 fields · synced May 18, 2026
- EUDAMED ed0287dc-a184-44a8-bd0f-ceeddd1cf712 61 fields · synced May 18, 2026
- EUDAMED 78398504-ed2a-49d8-9fd2-3c66d9b056fe 61 fields · synced May 18, 2026
- EUDAMED 91bc00a9-fa32-49a5-9573-74fa394f25ab 61 fields · synced May 18, 2026
- EUDAMED e29b946b-3828-49b5-b464-e527da471c37 61 fields · synced May 18, 2026
- EUDAMED 42d2ee07-87b1-4980-a59f-0493de926ef3 61 fields · synced May 19, 2026
- EUDAMED b40d9124-7ef0-4cb5-bb54-39dd3b8cf0cb 61 fields · synced May 19, 2026
- EUDAMED de9dd93f-61fe-4fba-9a25-d565eb152fa8 61 fields · synced May 19, 2026
- EUDAMED d099b3e2-fc4b-4f10-a9a3-6327b690e7ec 61 fields · synced May 19, 2026
- EUDAMED 8fa69d56-7443-4d79-90a6-88a32997b588 61 fields · synced May 19, 2026