Identity
- Trade Name
- Prevodová súprava PS EUDAMED
- Device Name
- Převodová souprava PS EUDAMED
- Model / Reference
- V606386-02ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540512185 EUDAMED
- Basic UDI-DI
- B-08593540512185 EUDAMED
- EMDN Code
- A03040202 OCULAR IRRIGATION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
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-08593540512185 | Class I | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 49402f94-ddc0-4311-b1ff-ab6093074dd1 61 fields · synced Jun 19, 2026