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Rapi-Diff II Stain Kit
EUDAMEDClass A (EU MDR)
Ref RRSK1-500Model Stain KitRef RRSK1-100
Identity
- Trade Name
- Rapi-Diff II Stain Kit EUDAMED
- Model / Reference
- Stain Kit EUDAMEDRRSK1-500 EUDAMEDRRSK1-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055914716016 EUDAMED05055914715996 EUDAMED
- Basic UDI-DI
- 505591470RRSKG4 EUDAMED
- Direct Marketing DI
- 05055914716016 EUDAMED05055914715996 EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMEDW01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDSweden 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
Rapi-Diff II Stain Kit 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 (4)
- EUDAMED 2a4ae672-a695-4ac5-a71a-c127348b8807 61 fields · synced Jul 27, 2026
- EUDAMED 3c2aea3e-6019-423b-921a-e1cd117e9bf5 61 fields · synced May 18, 2026
- EUDAMED b8f1cba5-c9b0-4712-8475-f23ad6445108 61 fields · synced Jul 22, 2026
- EUDAMED dac8ccde-69f6-4c96-854b-6112ae49b210 61 fields · synced Jul 27, 2026