Identity
- Device Name
- HDF on-line set EUDAMED
- Model / Reference
- V686435-ND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540512468 EUDAMED
- Basic UDI-DI
- B-08593540512468 EUDAMED
- EMDN Code
- F020180 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES 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
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
HDF on-line set by GAMA GROUP a.s. — Class IIa — 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-08593540512468 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 2c0f7ea9-a189-4bad-a498-06e5ade0a340 61 fields · synced Oct 6, 2026