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Gram Crystal Violet, reagens bez fenola, 250 mL
EUDAMEDClass A (EU MDR)
Ref GCF-OT-250
Identity
- Trade Name
- Gram Crystal Violet, reagens bez fenola, 250 mL EUDAMED
- Device Name
- Reagensi za mikrobiologiju EUDAMED
- Model / Reference
- GCF-OT-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892122648 EUDAMED
- Basic UDI-DI
- 385889212HPC4080299MCKA EUDAMED
- Direct Marketing DI
- 03858892122648 EUDAMED
- EMDN Code
- W0104080299 MANUAL IDENTIFICATION - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Gram Crystal Violet, reagens bez fenola, 250 mL by BioGnost Ltd. — 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 | 385889212HPC4080299MCKA | Class A | Active |
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Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED 2eaf49e8-1262-451d-9f6d-14d39298759b 61 fields · synced Oct 6, 2026