Identity
- Device Name
- Trocar Cannula EUDAMEDUniversal Trocar Cannula 12mm/100mm EUDAMED
- Model / Reference
- 899323 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127860978 EUDAMED
- Basic UDI-DI
- B-04714127860978 EUDAMED
- EMDN Code
- K01010199 TROCAR, SINGLE-USE - OTHER EUDAMEDK01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMEDSweden 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
Trocar Cannula 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-04714127860978 | 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 (2)
- EUDAMED 00ccebf0-5dd8-4943-bd86-6a9985f68871 61 fields · synced Oct 6, 2026
- EUDAMED d0ccab2c-4301-4fb8-99c6-e77778791c0d 61 fields · synced Jul 26, 2026