RAPIDPoint® 500e System Refurbish
by Siemens Healthcare Diagnostics Inc. 2 variants
Ref 11555832Model IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0405686901944WB 00630414658766 | Date21 Aug 2026 | StatusActive |
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- Withdrawn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/IVDR Active
Specification
- Device Name
- IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint
- Model / Reference
- IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint, 11555832
- Primary DI / UDI-DI
- 00630414658766
- Basic UDI-DI
- 0405686901944WB
- EMDN Code
- W0201040180 Blood gas analysers - hardware accessories
- Device Class
- Class A
- EU market of registration
- Belgium
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
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
- New Device: No