FDA Registration
Active
🇬🇧 United Kingdom
RAPIDPoint® 500e Blood Gas System
Reg #: 9610633
·
FEI: 3002806693
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD
- Registration Number
- 9610633
- FEI Number
- 3002806693
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NORTHERN RD., CHILTON INDUSTRIAL ESTATE
- City
- SUDBURY Suffolk
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K192240
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
US Agent
- Business Name
- Siemens Healthcare Diagnostics Inc.
- Contact Name
- Felix Akinrinola
- Address
- Point Of Care Headquarters, 333 Coney Street
- City
- East Walpole
- State
- MA
- ZIP
- 02032
- Country
- US
- [email protected]
- Phone
- 781 8561738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2020-03-30 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2020-03-30 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2020-03-30 |
Proprietary Names
RAPIDPoint® 500e Blood Gas System
iCa++ Quick Sampler
Establishment Types
Manufacture Medical Device