Identity
- Trade Name
- Urodynamická súprava malá USM EUDAMED
- Device Name
- Urodynamická souprava malá USM EUDAMED
- Model / Reference
- V606481-ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540507327 EUDAMED
- Basic UDI-DI
- B-08593540507327 EUDAMED
- EMDN Code
- U0599 URODYNAMICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Urodynamická súprava malá USM by GAMA GROUP a.s. — 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-08593540507327 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 5e0bb9fb-51a8-4298-82b9-26cc355bc92e 61 fields · synced Oct 6, 2026