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Gram Crystal Violet, reagens bez fenola, 100 mL
EUDAMEDClass A (EU MDR)
Ref GCF-OT-100
Identity
- Trade Name
- Gram Crystal Violet, reagens bez fenola, 100 mL EUDAMED
- Device Name
- Reagensi za mikrobiologiju EUDAMED
- Model / Reference
- GCF-OT-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892124185 EUDAMED
- Basic UDI-DI
- 385889212HPC4080299MCKA EUDAMED
- Direct Marketing DI
- 03858892124185 EUDAMED
- EMDN Code
- W0104080299 MANUAL IDENTIFICATION - OTHER EUDAMED
Classification
- Device Class
- Class A 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, 100 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 69f8ced8-429c-4705-bf40-dd8cdba68e50 61 fields · synced Jul 9, 2026