Identity
- Trade Name
- BIO-FLASH Sample Diluent EUDAMED
- Device Name
- BIO-FLASH EUDAMED
- Model / Reference
- 3000-8207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426950589433 EUDAMED
- Basic UDI-DI
- 84269506397259T EUDAMED
- Direct Marketing DI
- 08426950589433 EUDAMED
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
BIO-FLASH Sample Diluent by Biokit, S.a. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 84269506397259T | Class A | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED c9989a01-f904-4889-bdaa-0e428643f96b 61 fields · synced Jun 17, 2026