Identity
- Trade Name
- Tissue marking dye BOLD, blue, 50 mL EUDAMED
- Device Name
- Reagensi za bojenje EUDAMED
- Model / Reference
- TMDB5-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858890008784 EUDAMED
- Basic UDI-DI
- 385889212HPC30708STARVF EUDAMED
- Direct Marketing DI
- 03858890008784 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
Learn about the Tissue marking dye BOLD, blue, 50 mL device used for tissue marking and analysis in medical research. This device is designed for use in various applications, including histology and pathology studies.
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 f43d018a-2806-473e-95d3-75c8bd38c5ac 61 fields · synced Jul 10, 2026