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Biomark Applicator Sticks (for tissue marking dyes)
EUDAMEDClass A (EU MDR)
Ref BIOMAPPLIC-001Model Tissue Marking Dye
Identity
- Trade Name
- Biomark Applicator Sticks (for tissue marking dyes) EUDAMED
- Model / Reference
- Tissue Marking Dye EUDAMEDBIOMAPPLIC-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060405295376 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 Applicator Sticks (for tissue marking dyes) 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 69845b2e-093b-4488-acdb-79973eb694c6 61 fields · synced Jul 18, 2026