← Back to catalogue
Tissue marking dyes BOLD, fixative solution, 1000 mL
EUDAMEDClass A (EU MDR)
Ref TMDBFS-1L
Identity
- Trade Name
- Tissue marking dyes BOLD, fixative solution, 1000 mL EUDAMED
- Device Name
- Reagensi za bojenje EUDAMED
- Model / Reference
- TMDBFS-1L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858890008692 EUDAMED
- Basic UDI-DI
- 385889212HPC30708STARVF EUDAMED
- Direct Marketing DI
- 03858890008692 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
Tissue marking dyes BOLD, fixative solution, 1000 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED ba9bd307-a46b-445e-9669-34b671832701 61 fields · synced Jul 23, 2026