Identity
- Trade Name
- TB Malachite Green reagens, 500 mL EUDAMED
- Device Name
- Reagensi za mikrobiologiju EUDAMED
- Model / Reference
- TBM-OT-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858888824341 EUDAMED
- Basic UDI-DI
- 385889212HPC4080299MCKA EUDAMED
- Direct Marketing DI
- 03858888824341 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
TB Malachite Green reagens, 500 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 9fee3b21-e6bb-4054-b8e2-651417e47ea1 61 fields · synced Jun 19, 2026