Data / Medical devices / United Kingdom / Caltag Medsystems Ltd
Caltag Medsystems Ltd: FDA-registered device maker in Buckingham Buckinghamshire, United Kingdom, 1 510(k) clearance
Caltag Medsystems Ltd is registered with the FDA (registration 3003315146) in Buckingham Buckinghamshire, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 22, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003315146
- Address
- Whiteleaf Business Centre 11 Little Balmer, Buckingham Buckinghamshire, United Kingdom, MK18 1TF
- Owner or operator
- Caltag Medsystems (10052081)
- Roles
- Manufacturer
- First device listed
- June 10, 2016
- Registered through
- 2026
- Brand names listed
- TransFix, TransFix/EDTA Vacuum Blood Collection Tubes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 22, 2017 | K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | GIM | Substantially Equivalent | Caltag Medsystems, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 22, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.