Identity
- Trade Name
- SKALA OK3-V1 Perfusion set EUDAMED
- Device Name
- SKALA OK3-V1 Lavážní set EUDAMED
- Model / Reference
- V606501-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540505651 EUDAMED
- Basic UDI-DI
- B-08593540505651 EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SKALA OK3-V1 Perfusion 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-08593540505651 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 1ef81634-832a-4266-be1e-ec89851efee1 61 fields · synced Jul 11, 2026