Identity
- Trade Name
- Urodynamická souprava malá USM M EUDAMED
- Device Name
- Urodynamická souprava EUDAMED
- Model / Reference
- V606481-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540514042 EUDAMED
- Basic UDI-DI
- 85935406TF14URODYNAMIKAAD 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Urodynamická souprava malá USM M by GAMA GROUP a.s. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85935406TF14URODYNAMIKAAD | Class IIa | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 266ac122-2166-4952-9f8c-cecf87b7aa25 61 fields · synced Aug 1, 2026