Drawbridge Health, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Drawbridge Health, Inc. makes
Drawbridge Health, Inc. manufactures capillary blood collection systems for in vitro diagnostics (IVD), including the OneDraw A1C Test System and NanoDrop Lancet. These devices are designed for blood sampling and glucose monitoring, enabling point-of-care testing for hemoglobin A1C levels and other blood-based diagnostics.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is regulated in the United States.
Catalogue
- GUDID
OneDraw A1C Test System Ref K183230
510(k) 510(k)NanoDrop Lancet Ref K223826
510(k) 510(k)
Company details
- DUNS number
- 048087575
- [email protected]
- Phone
- 843-494-5082
Frequently asked questions
How many devices does Drawbridge Health, Inc. have in the registry?
The registry currently lists 3 devices for Drawbridge Health, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Drawbridge Health, Inc.'s devices?
Among its 3 most recently registered devices, Drawbridge Health, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Drawbridge Health, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Drawbridge Health, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Drawbridge Health, Inc. in the registry?
The most recently registered devices listed for Drawbridge Health, Inc. include OneDraw A1C Test System FD001, OneDraw A1C Test System and NanoDrop Lancet.