Potassium Hydroxide 20% Solution
by Atom Scientific Ltd 3 variants
Ref RRSP148-EModel Biological Stain
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number505591470RRSPGE | Date27 May 2026 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Biological Stain, RRSP148-E
- Primary DI / UDI-DI
- 05055914746280
- Basic UDI-DI
- 505591470RRSPGE
- EMDN Code
- W01030708 Stain solutions (histology/cytology)
- Device Class
- Class A
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- UK-MF-000046578
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Atom Scientific Ltd
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No