← Back to catalogue
TB Fluorescent Stain Kit II (Auramine Rhodamine Phenol)
EUDAMEDClass A (EU MDR)
Ref RRSK19-1000Model Stain Kit
Identity
- Trade Name
- TB Fluorescent Stain Kit II (Auramine Rhodamine Phenol) EUDAMED
- Model / Reference
- Stain Kit EUDAMEDRRSK19-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055914720150 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
TB Fluorescent Stain Kit II (Auramine Rhodamine Phenol) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atom Scientific Ltd
- EUDAMED SRN
- UK-MF-000046578
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 9508ca46-7be0-4c17-8621-93c89726a44a 61 fields · synced Jul 14, 2026