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Biomark Blue Tissue Marking Dye
EUDAMEDClass A (EU MDR)
Ref BIOMBLUE-CModel Tissue Marking Dye
Identity
- Trade Name
- Biomark Blue Tissue Marking Dye EUDAMED
- Model / Reference
- Tissue Marking Dye EUDAMEDBIOMBLUE-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060405295451 EUDAMED
- Basic UDI-DI
- 505591470BIOMAX EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
Biomark Blue Tissue Marking Dye by Atom Scientific 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 | 505591470BIOMAX | Class A | Active |
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Manufacturer
- Manufacturer
- Atom Scientific Ltd
- EUDAMED SRN
- UK-MF-000046578
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 936d36a3-cec0-4bd1-8443-e497b4788a3e 61 fields · synced Jul 17, 2026