Helmer Inc

FDA Filings

This page includes the latest FDA filings for Helmer Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Helmer Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004973569
FEI Number3004973569
NameHELMER INC.
Owner & OperatorHELMER INC.
Contact Address14400 BERGEN BLVD. --
Noblesville IN 46060 US
Official Correspondent
  • RENEE - SCHULTZ
  • x-317-2193985-3985
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address14400 Bergen Blvd
NOBLESVILLE, IN 46060 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
HELMER, INC.
Helmer 2024-05-09
HELMER, INC.
i.Series® 51100202023-10-16
HELMER, INC.
i.Series® 2023-10-10
HELMER, INC.
i.Series Platelet Incubator 2022-12-09
HELMER, INC.
i.Series Platelet Incubator 2022-12-09
HELMER, INC.
i.Series® 2019-03-11
HELMER, INC.
i.Series® 2019-03-11
HELMER, INC.
i.Series® 2019-03-11
HELMER, INC.
i.Series® 2019-03-11
HELMER, INC.
i.Series® 2019-03-11
HELMER, INC.
i.Series® 2019-03-11
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ 2019-03-04
HELMER, INC.
i.Series® 2019-03-04
HELMER, INC.
Horizon Series™ N/A2019-03-04
HELMER, INC.
i.Series® N/A2019-02-18
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
Horizon Series™ 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER, INC.
i.Series® 2018-06-26
HELMER INC.
UltraCW II2018-03-19
Helmer Inc.
Automated Cell-washing Centrifuge For Immune-hematology2018-01-22
HELMER INC.
iLF125 Laboratory Freezer2017-08-08
HELMER INC.
iLF120 Laboratory Freezer2017-08-08
HELMER INC.
iLF105 Laboratory Freezer2017-08-08
HELMER INC.
iLF104 Laboratory Freezer2017-08-08
HELMER INC.
HLF125 Laboratory Freezer2017-08-08
HELMER INC.
HLF120 Laboratory Freezer2017-08-08
HELMER INC.
HLF105 Laboratory Freezer2017-08-08
HELMER INC.
HLF104 Laboratory Freezer2017-08-08
HELMER INC.
UltraCW2012-11-14
HELMER INC.
PLASMA THAWING SYSTEM2004-09-08
HELMER INC.
HELMER PLATELET AGITATOR2004-09-08
HELMER INC.
HELMER PLATELET INCUBATOR2004-09-08
HELMER INC.
iUF126-GX2000-12-04
HELMER INC.
iUF126 Ultra-Low Freezer2000-12-04
HELMER INC.
iUF124-GX2000-12-04
HELMER INC.
iUF124 Ultra-Low Freezer2000-12-04
HELMER INC.
iUF118-GX2000-12-04
HELMER INC.
iUF118 Ultra-Low Freezer2000-12-04
HELMER INC.
iUF116-GX2000-12-04
HELMER INC.
iUF116 Ultra-Low Freezer2000-12-04
HELMER INC.
iPR458-GX2000-12-04
HELMER INC.
iPR256-GX2000-12-04
HELMER INC.
iPR245-GX2000-12-04
HELMER INC.
iPR226-GX2000-12-04
HELMER INC.
iPR125-GX2000-12-04
HELMER INC.
iPR120-GX2000-12-04
HELMER INC.
iPR113-GX2000-12-04
HELMER INC.
iPR105-GX2000-12-04
HELMER INC.
iPF125 Plasma Freezer2000-12-04
HELMER INC.
iPF120 Plasma Freezer2000-12-04
HELMER INC.
iPF105 Plasma Freezer2000-12-04
HELMER INC.
iPF104-ADA Plasma Freezer2000-12-04
HELMER INC.
iLR256-GX2000-12-04
HELMER INC.
iLR245-GX2000-12-04
HELMER INC.
iLR125-GX2000-12-04
HELMER INC.
iLR120-GX2000-12-04
HELMER INC.
iLR113-GX2000-12-04
HELMER INC.
iLR105-GX2000-12-04
HELMER INC.
iLF125-GX2000-12-04
HELMER INC.
iLF120-GX2000-12-04
HELMER INC.
iLF105-GX2000-12-04
HELMER INC.
iBR458-GX2000-12-04
HELMER INC.
iBR256-GX2000-12-04
HELMER INC.
iBR245-GX2000-12-04
HELMER INC.
iBR226-GX2000-12-04
HELMER INC.
iBR125-GX2000-12-04
HELMER INC.
iBR120-GX2000-12-04
HELMER INC.
iBR113-GX2000-12-04
HELMER INC.
iBR105-GX2000-12-04
HELMER INC.
iBF125-GX2000-12-04
HELMER INC.
iBF120-GX2000-12-04
HELMER INC.
iBF105-GX2000-12-04
HELMER INC.
iB456 Blood Bank Pass-Thru Refrigerator2000-12-04
HELMER INC.
iB256 Blood Bank Refrigerator2000-12-04
HELMER INC.
iB245 Blood Bank Refrigerator2000-12-04
HELMER INC.
iB225 Blood Bank Pass-Thru Refrigerator2000-12-04
HELMER INC.
iB125 Blood Bank Refrigerator2000-12-04
HELMER INC.
iB120 Blood Bank Refrigerator2000-12-04
HELMER INC.
iB111 Blood Bank Refrigerator2000-12-04
HELMER INC.
iB104-ADA Blood Bank Refrigerator2000-12-04
HELMER INC.
HPR458-GX2000-12-04
HELMER INC.
HPR256-GX2000-12-04
HELMER INC.
HPR245-GX2000-12-04
HELMER INC.
HPR226-GX2000-12-04
HELMER INC.
HPR125-GX2000-12-04
HELMER INC.
HPR120-GX2000-12-04
HELMER INC.
HPR113-GX2000-12-04
HELMER INC.
HPR105-GX2000-12-04
HELMER INC.
HPF125 Plasma Freezer2000-12-04
HELMER INC.
HPF120 Plasma Freezer2000-12-04
HELMER INC.
HPF105 Plasma Freezer2000-12-04
HELMER INC.
HPF104-ADA Plasma Freezer2000-12-04
HELMER INC.
HLR256-GX2000-12-04
HELMER INC.
HLR245-GX2000-12-04
HELMER INC.
HLR125-GX2000-12-04
HELMER INC.
HLR120-GX2000-12-04
HELMER INC.
HLR113-GX2000-12-04
HELMER INC.
HLR105-GX2000-12-04
HELMER INC.
HLF125-GX2000-12-04
HELMER INC.
HLF120-GX2000-12-04
HELMER INC.
HLF105-GX2000-12-04
HELMER INC.
HBR458-GX2000-12-04
HELMER INC.
HBR256-GX2000-12-04
HELMER INC.
HBR245-GX2000-12-04
HELMER INC.
HBR226-GX2000-12-04
HELMER INC.
HBR125-GX2000-12-04
HELMER INC.
HBR120-GX2000-12-04
HELMER INC.
HBR113-GX2000-12-04
HELMER INC.
HBR105-GX2000-12-04
HELMER INC.
HBF125-GX2000-12-04
HELMER INC.
HBF120-GX2000-12-04
HELMER INC.
HBF105-GX2000-12-04
HELMER INC.
HB456 Blood Bank Pass-Thru Refrigerator2000-12-04
HELMER INC.
HB256 Blood Bank Refrigerator2000-12-04
HELMER INC.
HB245 Blood Bank Refrigerator2000-12-04
HELMER INC.
HB225 Blood Bank Pass-Thru Refrigerator2000-12-04
HELMER INC.
HB125 Blood Bank Refrigerator2000-12-04
HELMER INC.
HB120 Blood Bank Refrigerator2000-12-04
HELMER INC.
HB111 Blood Bank Refrigerator2000-12-04
HELMER INC.
HB105 Blood Bank Refrigerator2000-12-04
HELMER INC.
HB104-ADA Blood Bank Refrigerator2000-12-04

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020082141031Nhava Sheva,India -> New York/Newark Area, Newark, New JerseyHS CODE 40094100 EPDM RUBBER HOSES2 PKG
2020081342311Nhava Sheva,India -> New York/Newark Area, Newark, New JerseyCOMPLETE RADIATORS HS CODE 870891004 PKG
2020081342312Nhava Sheva,India -> New York/Newark Area, Newark, New JerseyHS CODE 87089100 COMPLETE RADIATORS385 PKG
2019062730374Singapore,Singapore -> Long Beach, CaliforniaELECTRONIC EQUIPMENT1 PKG
2019061066791Singapore,Singapore -> Los Angeles, CaliforniaELECTRONIC EQUIPMENT1 PKG
2018063027114Genova,Italy -> Savannah, GeorgiaREFRIGERANT CHARGING MACHINES1 CAS
2018031013824Hong Kong,Hong Kong -> Long Beach, CaliforniaINCUBATOR COOLING SYSTEM600 CTN
2018030822097Hong Kong,Hong Kong -> Long Beach, CaliforniaINCUBATOR COOLING SYSTEM600 CTN

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