Identity
- Trade Name
- Prevodová súprava PS EUDAMEDPrevodová súprava EUDAMED
- Device Name
- Převodová souprava PS EUDAMEDPřevodová souprava EUDAMED
- Model / Reference
- V606386-03ND EUDAMEDV606386-ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540507532 EUDAMED08593540508669 EUDAMED
- Basic UDI-DI
- B-08593540507532 EUDAMEDB-08593540508669 EUDAMED
- EMDN Code
- A03040202 OCULAR IRRIGATION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMEDCzechia 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
Prevodová súprava PS by GAMA GROUP a.s. — Class I — 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-08593540507532 | Class I | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (2)
- EUDAMED 845cf8d0-b72b-4173-9888-cc42122f954a 61 fields · synced Jul 16, 2026
- EUDAMED 573d0a19-9d3b-4092-8765-4b774468bb96 61 fields · synced May 18, 2026