Hadleigh Health Technologies
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000022818 FEI 3030597679
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Pumani Ref 3-597
Regimes: CE MDD Registry: EUDAMEDPocket Colposcope System Ref K181034
Regimes: 510(k) Registry: 510(k)Celsi Monitor Ref K230298
Regimes: 510(k) Registry: 510(k)Celsi Warmer Ref K242964
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000022818
- FDA FEI number
- 3030597679
- EUDAMED status
- Active
- EUDAMED registered name
- Hadleigh Health Technologies
- EUDAMED abbreviated name
- HHT
- Registered address
- 200, Gate 5 Way, 94965, Sausalito, United States
- Website
- hadleighhealth.com
- [email protected]
- Phone
- +15106733653
- PRRC contact
- Eli Gross
From the company website
We design and manufacture innovative health technologies for the global marketplace.
Frequently asked questions
How many devices does Hadleigh Health Technologies have in the registry?
The registry currently lists 4 devices for Hadleigh Health Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hadleigh Health Technologies's devices?
Among its 4 most recently registered devices, Hadleigh Health Technologies has devices listed in EUDAMED (1 device) and FDA 510(k) (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hadleigh Health Technologies's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Hadleigh Health Technologies's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hadleigh Health Technologies in the registry?
The most recently registered devices listed for Hadleigh Health Technologies include Pumani, Pocket Colposcope System, Celsi Monitor and Celsi Warmer.