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Biomark Black Tissue Marking Dye
EUDAMEDClass A (EU MDR)
Ref BIOMBLACK-CModel Tissue Marking Dye
Identity
- Trade Name
- Biomark Black Tissue Marking Dye EUDAMED
- Model / Reference
- Tissue Marking Dye EUDAMEDBIOMBLACK-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060405295413 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 Black Tissue Marking Dye is a high-precision medical device that uses a proprietary dye to mark tissue for surgical and diagnostic purposes. This innovative technology provides accurate and reliable results, making it an essential tool in various medical procedures. By utilizing advanced spectroscopy and machine learning algorithms, Biomark Black Tissue Marking Dye ensures precise marking of tissues, even in complex geometries.
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 20edaee9-aee5-4dae-9f61-ea610c6286f7 61 fields · synced Jul 21, 2026