FDA Registration
Active
🇬🇧 United Kingdom
Biomedical Data Solutions Limited
Reg #: 3003966680
·
FEI: 3003966680
·
Expires 2026
Products
3
Proprietary Names
23
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Biomedical Data Solutions Limited
- Registration Number
- 3003966680
- FEI Number
- 3003966680
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Millennium Court, First Avenue, Centrum 100
- City
- BURTON ON TRENT Staffordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- BK160125
Owner / Operator
- Firm Name
- Biomedical Data Solutions Limited
- Operator Number
- 9054990
- Address
- Millennium Court, First Avenue, Centrum 100
- City
- BURTON ON TRENT
- State
- Staffordshire
- Postal Code
- DE14 2WH
- Country
- GB
- Correspondent
- Rebecca Stead
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Data Acquisition Software | PQQ | Class 2 | Clinical Chemistry | No | 2018-09-19 |
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2020-07-09 |
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2012-12-17 |
Proprietary Names
Procleix NAT Manager v1.2 Software
Procleix NAT Manager v1.3 Software
Procleix NAT Manager V1.4 Software
Ortho Connect 3
Ortho Connect 3.2
Ortho Connect 3.2.1
Ortho Connect 3.2.3
Ortho Connect 31
Ortho Connect 3.2.2
Ortho Connect 3.2.4
Aurora TOUCH
Sanguin Aurora v2
Aurora Gold V3
Aurora Gold V3.2
Aurora Gold V2
Aurora Enterprise
Procleix NAT Manager Software (Version 1.1)
Sanguin Liberty SR Import v3.1
ORTHO CONNECT
cobas Synergy Software
Cobas Synergy V1.4
Cobas Synergy V1.3
Cobas Synergy V1.5
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device