pH-Fix 2.0 - 9.0 PT
by MACHEREY-NAGEL GmbH & Co. KG EUDAMED
Active
Ref 92117Model pH-Fix 4.5 - 10.0 PT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number4046681152337WS | Date26 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 1038121-1 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 16 May 2023
- Expires
- 15 May 2028
Specification
- Device Name
- pH-Fix 4.5 - 10.0 PT
- Model / Reference
- pH-Fix 4.5 - 10.0 PT, 92117
- Primary DI / UDI-DI
- 04046681152962
- Basic UDI-DI
- 4046681152337WS
- EMDN Code
- W01010699 Clin. chem. rt & poc - other
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005636
Other devices from MACHEREY-NAGEL GmbH & Co. KG
Properties
Show properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No