Identity
- Device Name
- Optical Trocar 11mm/100mm EUDAMED
- Model / Reference
- 899318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127861111 EUDAMED
- Basic UDI-DI
- B-04714127861111 EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Optical Trocar 11mm/100mm 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-04714127861111 | 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 9e2f0af2-3cc1-4fbf-a2fd-a090948e132e 61 fields · synced Jun 20, 2026