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HELMER, INC.

USA · Noblesville

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 3Class II 3Class III 0

plus 6 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 3

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 2Class 2a 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States6 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: HELMER Inc. · HELMER INC. · HELMER, INC.

FDA listed device types

Chamber, Environmental For The Storage Of Platelet Concentrate 1Refrigerator, Freezer, Blood Storage 1Centrifuge, Cell-Washing, Automated For Immuno-Hematology 1Freezer 1Device, Blood Mixing And Blood Weighing 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10234400190	FREEZER ULTRA LOW	Class II
BR	10234400099	REFRIGERADORES PARA BANCO DE SANGUE E LABORATÓRIO HELMER	Class II
BR	10234400107	FREEZERS PARA BANCO DE SANGUE E LABORATÓRIO HELMER	Class II

HELMER, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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