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Cold Kinyoun Stain Kit (Methylene Blue Counterstain)
EUDAMEDClass A (EU MDR)
Ref RRSK8-1000Model Stain Kit
Identity
- Trade Name
- Cold Kinyoun Stain Kit (Methylene Blue Counterstain) EUDAMED
- Model / Reference
- Stain Kit EUDAMEDRRSK8-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055914760880 EUDAMED
- Basic UDI-DI
- 505591470RRSKG4 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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
Cold Kinyoun Stain Kit (Methylene Blue Counterstain) 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 | 505591470RRSKG4 | 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 08b815c3-4bf2-44b7-b973-aa9b151317f1 61 fields · synced Jun 19, 2026