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Potassium Hydroxide 0.2% in 80% Ethanol
EUDAMEDClass A (EU MDR)
Ref RRSP181-EModel Biological Stain
Identity
- Trade Name
- Potassium Hydroxide 0.2% in 80% Ethanol EUDAMED
- Model / Reference
- Biological Stain EUDAMEDRRSP181-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055914740691 EUDAMED
- Basic UDI-DI
- 505591470RRSPGE 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
Potassium Hydroxide 0.2% in 80% Ethanol 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 | 505591470RRSPGE | 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 c4c2aa0d-e7a1-406f-857d-32196d1174dc 61 fields · synced Jul 27, 2026