Helmer Scientific
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000003326
- Devices
- 9
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
i.Series Ref iLR256-GXC
Regimes: CE MDR Registry: EUDAMEDi.Series Ref iPR245-GXC
Regimes: CE MDR Registry: EUDAMEDi.Series Ref iPR256-GXC
Regimes: CE MDR Registry: EUDAMEDHorizon Series Ref HLR245-GXC
Regimes: CE MDR Registry: EUDAMEDi.Series Ref iLR245-GXC
Regimes: CE MDR Registry: EUDAMEDHorizon Series Ref HPR245-GXC
Regimes: CE MDR Registry: EUDAMEDHorizon Series Ref HPR256-GXC
Regimes: CE MDR Registry: EUDAMEDHorizon Series Ref HLR256-GXC
Regimes: CE MDR Registry: EUDAMEDi.Series Ref iLR125-GXC
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000003326
- EUDAMED status
- Active
- EUDAMED registered name
- Helmer Scientific
- EUDAMED abbreviated name
- Helmer Inc.
- Registered address
- 14400, Bergen Blvd, 46060, Noblesville, United States
- Website
- www.helmerinc.com
- [email protected]
- Phone
- 3172193985
- PRRC contact
- Renee Schultz
Frequently asked questions
How many devices does Helmer Scientific have in the registry?
The registry currently lists 9 devices for Helmer Scientific. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helmer Scientific's devices?
Among its 9 most recently registered devices, Helmer Scientific has devices listed in EUDAMED (9 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Helmer Scientific's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Helmer Scientific's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Helmer Scientific in the registry?
The most recently registered devices listed for Helmer Scientific include i.Series and Horizon Series.