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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 3 of 4
DeviceModel / ReferenceRegistriesClassStatus
i.Series® iPR225
FDA UDI
Class IIActive
Horizon Series™ HBF105-GX
FDA UDI
Class IIActive
i.Series® iLR256
FDA UDI
Class IIActive
i.Series® iPR111
FDA UDI
Class IIActive
i.Series® iBF125-GX
FDA UDI
Class IIActive
i.Series® PF15i
FDA UDI
Class IUnknown
i.Series® PC100i
FDA UDI
Class IIUnknown
i.Series® iPR113-GX
FDA UDI
Class IIActive
Scientific Series™ SLR104-ADA
FDA UDI
Class IIActive
Horizon Series™ HB104-ADA
FDA UDI
Class IIActive
Farrar FUF126
FDA UDI
Class IIActive
Horizon Series™ HPR245-GX
EUDAMEDFDA UDI
Class IIActive
i.Series® iLR125
FDA UDI
Class IIActive
i.Series® iPR245-GX
FDA UDI
Class IIActive
i.Series® iBR120-GX
FDA UDI
Class IIActive
Horizon Series™ HLR111
FDA UDI
Class IIActive
i.Series® PC4200i
FDA UDI
Class IIActive
Horizon Series™ HLR256
FDA UDI
Class IIActive
i.Series® iBR113-GX
FDA UDI
Class IIActive
Helmer PC100-Pro
FDA UDI
Class IIActive
i.Series® PC1200i
FDA UDI
Class IIUnknown
i.Series® iUF124
FDA UDI
Class IIActive
QuickThaw® DH2
FDA UDI
Class IActive
i.Series® iLR113-GX
FDA UDI
Class IIActive
Horizon Series™ HLF125-GX
FDA UDI
Class IIActive
Horizon Series™ HLR113-GX
EUDAMEDFDA UDI
Class IIActive
Horizon Series™ HLR120
FDA UDI
Class IIActive
UltraCW®II UltraCW II
FDA UDI
Class IIActive
i.Series® PF48i
FDA UDI
Class IUnknown
i.Series® iPR456
FDA UDI
Class IIActive
i.Series® iPR226-GX
FDA UDI
Class IIActive
i.Series® iB456
FDA UDI
Class IIActive
i.Series® iPR458-GX
FDA UDI
Class IIActive
Horizon Series™ PF48h
FDA UDI
Class IUnknown
QuickThaw® DH8
EUDAMEDFDA UDI
Class IActive
Horizon Series™ HLR245
FDA UDI
Class IIActive
Horizon Series™ HBR125-GX
EUDAMEDFDA UDI
Class IIActive
i.Series® iUF126
FDA UDI
Class IIActive
Horizon Series™ PC1200h
FDA UDI
Class IIUnknown
Helmer PF48-Pro
FDA UDI
Class IActive
Horizon Series™ HPR120-GX
EUDAMEDFDA UDI
Class IIActive
i.Series® iBR256-GX
FDA UDI
Class IIActive
i.Series® PC2200i
FDA UDI
Class IIActive
Horizon Series™ HPR256
FDA UDI
Class IIActive
Horizon Series™ HPF120
FDA UDI
Class IIActive
Horizon Series™ HB256
FDA UDI
Class IIActive
Horizon Series™ HPF105
FDA UDI
Class IIActive
i.Series® PF396i
FDA UDI
Class IUnknown
i.Series® iPR120
FDA UDI
Class IIActive
i.Series® iLR125-GX
FDA UDI
Class IIActive

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