Multistix 10 Visual
by Siemens Healthcare Diagnostics Inc.
Ref 10323220Model IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat
Active
CE IVDR
Valid until
5 Jun 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0405686901963WF 00630414985039 | Date27 May 2026 | StatusActive |
Certificates
- IX 1290554-8 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 12 May 2025
- Expires
- 5 Jun 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat
- Model / Reference
- IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat, 10323220
- Primary DI / UDI-DI
- 00630414985039
- Basic UDI-DI
- 0405686901963WF
- Unit of Use DI
- 00630414306766
- EMDN Code
- W0101060204 Urine multi-constituent test strips (manual)
- Device Class
- Class B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000016560
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Other devices from Siemens Healthcare Diagnostics Inc.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No