Glenroe
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000056655 FEI 3040999583
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Regimes: CE MDR Registry: EUDAMEDGUDID
Platypus Ref AC150BAG
Regimes: CE MDR Registry: EUDAMEDGUDIDPlatypus Ref AC150-5
Regimes: CE MDR Registry: EUDAMEDGUDIDPlatypus Ref AC150-5BAG
Regimes: CE MDR Registry: EUDAMEDGUDIDGlenroe Golden Orthodontic Bracket Ref K923124
Regimes: 510(k) Registry: 510(k)Glenroe Glow In Dark Elastomeric Ligatures Ref K973495
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000056655
- FDA FEI number
- 3040999583
- EUDAMED status
- Active
- EUDAMED registered name
- Glenroe, LLC
- Registered address
- 555 W. Brown Deer Road, 53217, Milwaukee, United States
- Website
- www.platypusco.com
- [email protected]
- Phone
- +1(406)626-1736
- PRRC contact
- Bruce Deemer
Frequently asked questions
How many devices does Glenroe have in the registry?
The registry currently lists 6 devices for Glenroe. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glenroe's devices?
Among its 6 most recently registered devices, Glenroe has devices listed in EUDAMED (4 devices), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Glenroe's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Glenroe's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Glenroe in the registry?
The most recently registered devices listed for Glenroe include Platypus AC150, Platypus, GLENROE GOLDEN ORTHODONTIC BRACKET and GLENROE GLOW IN DARK ELASTOMERIC LIGATURES.