Ready Sensor™ GOLD pH Sensor 10312556
by Siemens Healthcare Diagnostics Inc.
Ref 10312556Model IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX
Active
CE IVDR
Valid until
8 Dec 2029
FDA recalls
Not checked
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0405686901946WF 00630414112145 | Date26 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00630414112145 | Date24 Sep 2016 | StatusListed |
Certificates
- IX 1290554-11 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 9 Dec 2024
- Expires
- 8 Dec 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Ready Sensor - pH EUDAMEDReady Sensor™ GOLD pH Sensor GUDID
- Generic Name
- Blood pH electrode
- Device Name
- IVDR_69_TTN_DUB-C_c_npt_reag_bg-348EX
- Model / Ref / Catalog
- 10312556, IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX, 476267
- Primary DI / UDI-DI
- 00630414112145
- Basic UDI-DI
- 0405686901946WF
- Unit of Use DI
- 00630414010106
- FDA Product Code
- CGA, CGZ, JGS, JFP, CEM, GKR, CHL, KHP
- EMDN Code
- W0101060604 Ph/po2/pco2 - electrodes (bg)
- GMDN Term
- Blood pH electrode
- Device Class
- Class C EUDAMEDClass II GUDID
- Regulation Number
- 862.1345, 862.1170, 862.1665, 862.1145, 862.1600, 864.5620, 862.1120, 862.1450
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class C | Class II |
Other devices from Siemens Healthcare Diagnostics Inc.
Properties
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No