Identity
- Device Name
- Bladed Trocar EUDAMED
- Model / Reference
- FSTD05100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127864099 EUDAMED
- Basic UDI-DI
- B-04714127864099 EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, 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
Bladed Trocar by Unimax Medical Systems Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04714127864099 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 81d63727-240f-45ea-9d2b-e0249ba05d39 61 fields · synced Oct 7, 2026