Genteel, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000054248 FEI 3012677227
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Genteel, LLC makes
Genteel, LLC makes the Genteel Lancing Device, a medical device used for obtaining capillary blood samples.
The Genteel Lancing Device is classified as a Class II device and is listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Genteel Ref 250912
Regimes: CE MDR Registry: EUDAMEDGenteel Lancing Device Ref K153670
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000054248
- FDA FEI number
- 3012677227
- EUDAMED status
- Active
- EUDAMED registered name
- Genteel
- Registered address
- 2904 Rawhide St, 97068, West Linn, United States
- Website
- www.mygenteel.com
- [email protected]
- PRRC contact
- Dr Christopher Jacobs
Frequently asked questions
How many devices does Genteel, LLC have in the registry?
The registry currently lists 2 devices for Genteel, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genteel, LLC's devices?
Among its 2 most recently registered devices, Genteel, LLC has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Genteel, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genteel, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genteel, LLC in the registry?
The most recently registered devices listed for Genteel, LLC include Genteel and Genteel Lancing Device.