Identity
- Device Name
- Optical Balloon Trocar EUDAMEDOptical Balloon Trocar 12mm/100mm EUDAMED
- Model / Reference
- 899328 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127860558 EUDAMED
- Basic UDI-DI
- B-04714127860558 EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, 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
Optical Balloon 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-04714127860558 | 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 5d6bdcc1-c5a7-4231-8c46-058984401f3c 61 fields · synced Oct 6, 2026
- EUDAMED 5df3a221-c6bf-46e6-8081-0af54791a101 61 fields · synced Jul 10, 2026