Hemosure Inc.
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Hemosure Inc. is a medical device manufacturer, with 192 devices listed in FDA GUDID (FDA Class II, Unclassified and Class I) as of 14 Nov 2026.
- Devices
- 192
Registry facts
- Registries
- FDA GUDID 192
- Device classes
- FDA Class II 176
- FDA Unclassified 8
- FDA Class I 4
- Identifiers
- DUNS 806777541
What Hemosure Inc. makes
The company manufactures in-vitro diagnostic (IVD) kits and controls for rapid immunochromatographic testing (ICT), primarily designed for clinical use. These include tests for drugs of abuse (such as morphine, methamphetamine, and amphetamines), faecal occult blood, and human chorionic gonadotropin (hCG). Control products are also produced to validate test performance.
The portfolio consists of Class I, Class II, and unclassified (U) devices, all listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 192 devicesShowing 1-50 of 192
Company details
- DUNS number
- 806777541
Frequently asked questions
How many devices does HEMOSURE INC. have in the registry?
The registry currently lists 192 devices for HEMOSURE INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list HEMOSURE INC.'s devices?
Among its 50 most recently registered devices, HEMOSURE INC. has devices listed in FDA GUDID (50 devices).
What risk classes do HEMOSURE INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for HEMOSURE INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from HEMOSURE INC. in the registry?
The most recently registered devices listed for HEMOSURE INC. include First Sign FSCCUP-34124, FIRST SIGN® FSCW11024, FIRST SIGN® FSCDIP254 and First Sign® FSCCUP-13124 W/AD.