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Thoracic Trocar
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FTT106070510(k) K112358
Identity
- Device Name
- Thoracic Trocar EUDAMED
- Model / Reference
- FTT106070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127864709 EUDAMED
- Basic UDI-DI
- B-04714127864709 EUDAMED
- EMDN Code
- K01010104 THORACIC TROCAR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Thoracic Trocar by Unimax Medical Systems Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112358 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04714127864709 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- FDA Applicant
- Unimax Medical Systems, Inc.
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 0e165680-79be-4b55-aa66-e812b7b9eeb6 85 fields · synced Jun 20, 2026
- FDA 510(k) K112358 1 fields · synced May 18, 2026