Identity
- Trade Name
- Succinate dehydrogenase kit, for 25 tests EUDAMED
- Device Name
- Reagensi za bojenje EUDAMED
- Model / Reference
- SDH-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858890003628 EUDAMED
- Basic UDI-DI
- 385889212HPC30708STARVF EUDAMED
- Direct Marketing DI
- 03858890003628 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
Succinate dehydrogenase kit, for 25 tests by BioGnost Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Special staining kits for histology and citology
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 57faa3b5-6c12-4812-b78a-6f93ecdcd16f 61 fields · synced Jun 19, 2026