Cytochip, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000043146
Cytochip, Inc. is a medical device manufacturer based in the United States, with 5 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class II; EU Class A) as of 14 Nov 2026.
- Devices
- 5
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 3
- FDA GUDID 3
- FDA 510(k) 1
- Device classes
- FDA Class II 3
- EU Class A 1
- Top EMDN categories
- Identifiers
- EUDAMED SRN US-MF-000043146
- DUNS 081107751
At a glance
Market reach
- European Union
- EUDAMED actor
What Cytochip, Inc. makes
Cytochip, Inc. manufactures in vitro diagnostic (IVD) devices for haematological analysis, including full blood count control materials, cell count kits, and automated cell analysers. Their products include disposable cartridges for blood analysis and a system designed for laboratory use to measure haematological parameters.
The company’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries. Cytochip, Inc. is based in the United States.
Catalogue
CitoDx CBC Analyzer Ref 1130
Regimes: CE IVDR Registry: EUDAMED- Regimes: CE IVDD Registry: EUDAMEDGUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: CE IVDD Registry: EUDAMEDGUDID
Cito CBC System Ref K240402
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000043146
- DUNS number
- 081107751
- EUDAMED status
- Active
- EUDAMED registered name
- CytoChip Inc.
- Registered address
- 18, TECHNOLOGY DR, 92618-2313, Irvine, United States
- PRRC contact
- Yuan Gao
Frequently asked questions
How many devices does Cytochip, Inc. have in the registry?
The registry currently lists 5 devices for Cytochip, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cytochip, Inc.'s devices?
Among its 5 most recently registered devices, Cytochip, Inc. has devices listed in EUDAMED (3 devices), FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cytochip, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cytochip, Inc.'s devices are Class II and IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Cytochip, Inc. in the registry?
The most recently registered devices listed for Cytochip, Inc. include CitoDx CBC Analyzer, CitoCBC Control 1310, CitoCBC Analyzer 1110 and CitoCBC Cartridge 1210.