Medi-Test Keton
by MACHEREY-NAGEL GmbH & Co. KG 2 variants
Ref 93005Model Medi-Test URYXXON® Stick 10
Active
CE IVDR
Valid until
15 May 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 1038121-2 | Date22 Nov 2024 | StatusActive |
Certificates
- IX 1038121-2 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 22 Nov 2024
- Expires
- 15 May 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Medi-Test URYXXON® Stick 10
- Model / Reference
- Medi-Test URYXXON® Stick 10, 93005
- Primary DI / UDI-DI
- 04046681000065
- Basic UDI-DI
- 4046681151040VR
- EMDN Code
- W0101060201 Urine single test strips (incl. tablets)
- Device Class
- Class B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005636
Other devices from MACHEREY-NAGEL GmbH & Co. KG
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No