FORMALDEIDE 4% per Tissue Filling pH 7, 2-7, 4
by Kaltek S.r.l. EUDAMED
Active
Ref 1659
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number805551056formaldeide_4%BN | Date3 Aug 2026 | 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- Withdrawn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
- Formaldeide Al 4%
- Model / Reference
- 1659
- Primary DI / UDI-DI
- 08055510567583
- Basic UDI-DI
- 805551056formaldeide_4%BN
- EMDN Code
- W01030705 Fixing reagents (histology/cytology)
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000019573
Other devices from Kaltek S.r.l.
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