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Trocar Stability Sleeve
EUDAMEDClass IIa (EU MDR)
Ref TRE-06-NModel TR/TRO/TRC/TRE/TRA SeriesRef TRE-06L-NRef TRO-08Ref TRC-06LRef TRC-06-NRef TRC-12MRef TRE-06LRef TRA-06MRef TRA-06L-NRef TRE-06Ref TRC-11MRef TRC-11Ref TRA-06LRef TRA-06Ref TRA-06-NRef TRE-06M-NRef TRC-12
Identity
- Trade Name
- Trocar Stability Sleeve EUDAMED
- Device Name
- Trocar EUDAMED
- Model / Reference
- TR/TRO/TRC/TRE/TRA Series EUDAMEDTRE-06-N EUDAMEDTRE-06L-N EUDAMEDTRO-08 EUDAMEDTRC-06L EUDAMEDTRC-06-N EUDAMEDTRC-12M EUDAMEDTRE-06L EUDAMEDTRA-06M EUDAMEDTRA-06L-N EUDAMEDTRE-06 EUDAMEDTRC-11M EUDAMEDTRC-11 EUDAMEDTRA-06L EUDAMEDTRA-06 EUDAMEDTRA-06-N EUDAMEDTRE-06M-N EUDAMEDTRC-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123023704 EUDAMED04714123023735 EUDAMED04714123021618 EUDAMED04714123022851 EUDAMED04714123023186 EUDAMED04714123022912 EUDAMED04714123023728 EUDAMED04714123024787 EUDAMED04714123024770 EUDAMED04714123023711 EUDAMED04714123022868 EUDAMED04714123022875 EUDAMED04714123024763 EUDAMED04714123024756 EUDAMED04714123024800 EUDAMED04714123029379 EUDAMED04714123022837 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
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 (17)
- EUDAMED 528a1d6c-3284-4b6f-bb28-11a4b936a816 61 fields · synced Aug 4, 2026
- EUDAMED d9ee3c52-2519-4e49-8ca9-1aa2073ac47c 61 fields · synced May 16, 2026
- EUDAMED 80478e20-c6c7-4ccc-8462-2669fa67b6e8 61 fields · synced May 16, 2026
- EUDAMED 828cdb8b-6ca4-4900-896e-1d18ba6de7cd 61 fields · synced May 17, 2026
- EUDAMED 29807815-d4c2-44a3-a3e6-ed2d1970acca 61 fields · synced May 17, 2026
- EUDAMED 4fbd0eb6-9f3f-4782-8d49-045df380a752 61 fields · synced May 18, 2026
- EUDAMED d0bcfdd2-a742-47dd-afc1-b0c0029b371d 61 fields · synced May 18, 2026
- EUDAMED 55dbdded-2131-4213-9ea2-1d60617c559e 61 fields · synced May 18, 2026
- EUDAMED e13a26b0-3f5b-4d13-8cc8-8d3f8390ae25 61 fields · synced May 18, 2026
- EUDAMED 6bd1a2b2-3eac-4ced-95d1-2ea7961d78c2 61 fields · synced May 18, 2026
- EUDAMED 046ffc69-fd8d-4952-badb-f8ea09c6d15c 61 fields · synced May 18, 2026
- EUDAMED b141b2c1-e4fa-489b-b454-a315f141e7f6 61 fields · synced May 19, 2026
- EUDAMED 0e5c276e-e30a-489d-a0a0-04e9a0522ba9 61 fields · synced May 19, 2026
- EUDAMED 035cf868-0083-4d85-a24c-e8ed9af9887c 61 fields · synced May 19, 2026
- EUDAMED 00f58ed9-eded-4f93-98fa-a20e782e79bf 61 fields · synced May 19, 2026
- EUDAMED 6e35ff44-f9ca-4624-b839-bb591dab1279 61 fields · synced May 19, 2026
- EUDAMED 213711d2-d1d2-41f0-bb7d-456fc07ab6e4 61 fields · synced May 19, 2026