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HELMER Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
14400 Bergen Blvd, NOBLESVILLE, IN, 46060
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
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FDA FEI Number
3004973569
DUNS Number
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Catalogue (167)

Page 2 of 4
DeviceModel / ReferenceRegistriesClassStatus
i.Series® iPR125
FDA UDI
Class IIActive
i.Series® iPR105-GX
FDA UDI
Class IIActive
Horizon Series™ HLR245-GX
EUDAMEDFDA UDI
Class IIActive
Horizon Series™ HPR120
FDA UDI
Class IIActive
Horizon Series™ HB125
FDA UDI
Class IIActive
i.Series® iLR245-GX
FDA UDI
Class IIActive
Horizon Series™ HPR111
FDA UDI
Class IIUnknown
i.Series® iLR111
FDA UDI
Class IIActive
i.Series® iLF120-GX
FDA UDI
Class IIActive
i.Series® iLR245
FDA UDI
Class IIActive
Farrar FCF133
FDA UDI
Class IActive
Horizon Series™ HPF104-ADA
FDA UDI
Class IIActive
Horizon Series™ HLF105-GX
FDA UDI
Class IIActive
i.Series® iLF125
FDA UDI
Class IIActive
Helmer PF15-Pro
FDA UDI
Class IActive
i.Series® iBR458-GX
FDA UDI
Class IIActive
i.Series® iLR256-GX
FDA UDI
Class IIActive
Horizon Series™ HPR125-GX
EUDAMEDFDA UDI
Class IIActive
UltraCW® UltraCW
FDA UDI
Class IIActive
i.Series® iB120
FDA UDI
Class IIActive
Horizon Series™ PC900h
FDA UDI
Class IIUnknown
i.Series® iPR120-GX
FDA UDI
Class IIActive
i.Series® iLR120-GX
FDA UDI
Class IIActive
Horizon Series™ HLR125
FDA UDI
Class IIActive
Horizon Series™ PF96h
FDA UDI
Class IActive
Helmer PC2200-Pro
FDA UDI
Class IIActive
i.Series® iPR256
FDA UDI
Class IIActive
Horizon Series™ HBR226-GX
EUDAMEDFDA UDI
Class IIActive
i.Series® iLR105-GX
FDA UDI
Class IIActive
Helmer PC1200-Pro
FDA UDI
Class IIActive
i.Series® iB105
FDA UDI
Class IIActive
Horizon Series™ PF15h
FDA UDI
Class IUnknown
i.Series® iB225
FDA UDI
Class IIActive
i.Series® iBR125-GX
FDA UDI
Class IIActive
i.Series® iPF125
FDA UDI
Class IIActive
Horizon Series™ HLF120-GX
EUDAMEDFDA UDI
Class IIActive
i.Series® iPF120
FDA UDI
Class IIActive
Horizon Series™ HBR458-GX
EUDAMEDFDA UDI
Class IIActive
Horizon Series™ PC3200h
FDA UDI
Class IIActive
i.Series® iPF104-ADA
FDA UDI
Class IIActive
Helmer PC900-Pro
FDA UDI
Class IIActive
Horizon Series™ HLR125-GX
EUDAMEDFDA UDI
Class IIActive
Helmer PC3200-PRO
FDA UDI
Class IIActive
Horizon Series™ HLF120
FDA UDI
Class IIActive
i.Series® PC900i
FDA UDI
Class IIUnknown
Horizon Series™ HPR226-GX
EUDAMEDFDA UDI
Class IIActive
Horizon Series™ PC2200h
FDA UDI
Class IIActive
Helmer iUF126-GX
FDA UDI
Class IIActive
Horizon Series™ HLF105
FDA UDI
Class IIActive
i.Series® iB245
FDA UDI
Class IIActive

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