Identity
- Trade Name
- Priming set dialyzačných súprav PS 003 EUDAMED
- Device Name
- Priming set dialyzačních souprav PS 003 EUDAMED
- Model / Reference
- V606003-ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540508447 EUDAMED
- Basic UDI-DI
- B-08593540508447 EUDAMED
- EMDN Code
- F0304 DIALYSIS WASHING/FILLING KITS 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
Priming set dialyzačných súprav PS 003 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-08593540508447 | Class I | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 1e359a15-02dd-4769-8f23-bd86882e7354 61 fields · synced Jul 17, 2026