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Priming set dialyzačních souprav PS 003 M
EUDAMEDClass IIa (EU MDR)
Ref V606003-M
Identity
- Trade Name
- Priming set dialyzačních souprav PS 003 M EUDAMED
- Device Name
- Priming set dialyzačních souprav PS 003 M EUDAMED
- Model / Reference
- V606003-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540515438 EUDAMED
- Basic UDI-DI
- 85935406TF08PRIMINGSETUQ EUDAMED
- EMDN Code
- F0304 DIALYSIS WASHING/FILLING KITS 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
Priming set dialyzačních souprav PS 003 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 | 85935406TF08PRIMINGSETUQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED c7fe9c86-37f6-400f-acfe-14aaf2e1dda7 61 fields · synced Jul 9, 2026