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Cold Kinyoun Stain Kit (Malachite Green Counterstain)
EUDAMEDClass A (EU MDR)
Ref RRSK7-200Model Stain Kit
Identity
- Trade Name
- Cold Kinyoun Stain Kit (Malachite Green Counterstain) EUDAMED
- Model / Reference
- Stain Kit EUDAMEDRRSK7-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060405298773 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 (Malachite Green 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 1899b006-69ad-4712-8c6c-57224520954b 61 fields · synced Jul 20, 2026