Casebioscience, Inc.
CanadaFDA applicant, unverified FDA FEI 3025773437
Casebioscience, Inc. is a medical device manufacturer, with 9 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 14 Nov 2026.
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 7
- FDA 510(k) 2
- Device classes
- FDA Class II 9
- Identifiers
- FDA FEI 3025773437
- DUNS 209069774
At a glance
Market reach
- United States
- FDA FEI
What Casebioscience, Inc. makes
Casebioscience, Inc. produces in vitro fertilization (IVF) media, including culture and handling solutions for gametes and embryos. Their portfolio includes base culture media, handling media with human serum albumin (HSA), and specialized media such as HEPES-buffered solutions and human tubal fluid (HTF) variants.
These products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. The company operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3025773437
- DUNS number
- 209069774
- Address
- 24 Norwich Street East, Guelph Ontario
- Phone
- (226) 243-6483
Frequently asked questions
How many devices does Casebioscience, Inc. have in the registry?
The registry currently lists 9 devices for Casebioscience, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Casebioscience, Inc.'s devices?
Among its 9 most recently registered devices, Casebioscience, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Casebioscience, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Casebioscience, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Casebioscience, Inc. in the registry?
The most recently registered devices listed for Casebioscience, Inc. include CaseBioscience® CMON-050, CaseBioscience® WHMO-100, CaseBioscience® HTFC-100 and CaseBioscience® HHTF-100.