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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: —
FDA FEI Number: 3004973569
DUNS Number: —

Catalogue (167)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
i.Series®	iUF124-GX	FDA UDI	Class II	Unknown
Horizon Series™	HB456	FDA UDI	Class II	Active
Horizon Series™	HB225	FDA UDI	Class II	Active
i.Series®	iBX080	FDA UDI	Class II	Active
Horizon Series™	HLR104-ADA	FDA UDI	Class II	Active
i.Series®	iB104-ADA	FDA UDI	Class II	Active
i.Series®	iB111	FDA UDI	Class II	Active
Horizon Series™	HPR125	FDA UDI	Class II	Active
i.Series®	iB125	FDA UDI	Class II	Active
Horizon Series™	HPR245	FDA UDI	Class II	Active
Horizon Series™	HLR120-GX	EUDAMEDFDA UDI	Class II	Active
i.Series®	iLF105	FDA UDI	Class II	Active
Horizon Series™	PC100h	FDA UDI	Class II	Unknown
Horizon Series™	HPR225	FDA UDI	Class II	Active
Horizon Series™	HB120	FDA UDI	Class II	Active
Horizon Series™	HPF125	FDA UDI	Class II	Active
i.Series®	iBF120-GX	FDA UDI	Class II	Active

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