Identity
- Trade Name
- Zkumavka 10 ccm PS - sterilní EUDAMED
- Device Name
- Zkumavka 10 ccm PS - sterilní EUDAMED
- Model / Reference
- V400914 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540400284 EUDAMED
- Basic UDI-DI
- B-08593540400284 EUDAMED
- EMDN Code
- W050301020102 SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Zkumavka 10 ccm PS - sterilní by GAMA GROUP a.s. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08593540400284 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED a8849e62-a298-4775-809f-ee0ea84c1bb3 61 fields · synced Jul 14, 2026