Potassium Hydroxide Solution (10%) 1000 mL
by ScyTek Laboratories Inc. EUDAMED
Active
Ref PHC999
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number081010871W01030708FG | Date31 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Stain Solutions
- Model / Reference
- PHC999
- Primary DI / UDI-DI
- 00810213571637
- Basic UDI-DI
- 081010871W01030708FG
- Direct Marketing DI
- 00810213571637
- EMDN Code
- W01030708 Stain solutions (histology/cytology)
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000023816
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from ScyTek Laboratories Inc.
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