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UriGnost SM reagens, za 1000 testiranja, 100 mL
EUDAMEDClass A (EU MDR)
Ref UGSM-1000
Identity
- Trade Name
- UriGnost SM reagens, za 1000 testiranja, 100 mL EUDAMED
- Device Name
- Reagensi za bojenje EUDAMED
- Model / Reference
- UGSM-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858890008494 EUDAMED
- Basic UDI-DI
- 385889212HPC30708STARVF EUDAMED
- Direct Marketing DI
- 03858890008494 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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
UriGnost SM reagens, za 1000 testiranja, 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 | 385889212HPC30708STARVF | Class A | Active |
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Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED f23356a5-98b9-4694-b315-e9516dc1f600 61 fields · synced Oct 6, 2026