Identity
- Device Name
- Monopolar Scissor EUDAMED
- Model / Reference
- FMS533054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127866161 EUDAMED
- Basic UDI-DI
- B-04714127866161 EUDAMED
- EMDN Code
- K0201010402 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
Monopolar Scissor by Unimax Medical Systems Inc. — Class IIb — 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-04714127866161 | Class IIb | 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 c70da607-0f2f-4def-99b1-b35aa56c760e 61 fields · synced Oct 6, 2026