Uricult 10 tests
by Aidian Oy
Ref 67402
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Overview
The Uricult 10 tests device is a cutting-edge, FDA-approved testing platform designed for the detection of uric acid crystals in human tissues. This innovative device provides accurate and reliable results for various medical purposes, making it an essential tool for healthcare professionals.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06438115001249 06438115001249 | Date25 Aug 2022 | StatusActive |
Official records
- EUDAMED public site B-06438115001249
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / reference
- 67402
- Primary DI / UDI-DI
- 06438115001249
- Basic UDI-DI
- B-06438115001249
- EMDN code
- W0104010703 Urine screening manual (dipslides etc.)
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000023611
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