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HELENA LABORATORIES, CORP.

USA · Beaumont

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

50listed device types

Class I 19Class II 31Class III 0

plus 139 registration records and 283 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

51registered devices

Class I 9Class II 42

57 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

58active device licences

Class II 53Class III 5

85 including historic records

TWTaiwanTFDA

18valid device licences

Class I 10Class II 8

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

16active ARTG entries

IVD Class 1 3IVD Class 2 13

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States139 registration records, 283 510(k), 0 PMA

Brazil51 confirmed, 2 excluded

Canada58 confirmed, 0 excluded

Manufacturer names merged into this page: HELENA LABORATORIES, CORP. · Helena Laboratories UK Ltd · HELENA LABORATORIES, CORP · HELENA LABORATORIES (UK) LTD. TRADING AS HELENA BIOSCIENCES EUROPE · HELENA LABORATORIES · HELENA LABORATORIES, INC.

Same-named companies — This database also contains companies with near-identical names: Helena Laboratories Uk, Ltd., HELENA LABORATORIES (UK) LTD. TRADING AS HELENA BIOSCIENCES EUROPE. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

191991

191992

101993

101994

81995

81996

31997

61998

31999

22000

32001

72002

22003

12005

22006

12007

12010

12012

12013

22022

FDA listed device types

showing 8 of 50

Igm, Antigen, Antiserum, Control 1Test, Thrombin Time 1System, Analysis, Electrophoretic Hemoglobin 1Assay, Heparin 1Instrument, Coagulation, Automated 1Plasma, Control, Normal 1Igd, Antigen, Antiserum, Control 1Electrophoretic, Lactate Dehydrogenase Isoenzymes 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213396	SPIFE A1AT kit	2022-10-13
US	K192931	V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control	2022-04-19
US	K131479	V8 SP NORMAL CONTROL, ABNORMAL CONTROL	2013-10-07
BR	10230730101	Kit para Eletroforese SPIFE CK	Class II
BR	10230730097	Kit de Eletroforese para Lipoproteína	Class II
BR	10230730098	Proteína S Livre Monoclonal	Class II
CA	6185	TITAN GEL LD ISOENZYME KIT	Class II
CA	6188	TITAN GEL ISO DOT LD ISOENZYME KIT	Class II
CA	6871	L/S RATIO	Class II

HELENA LABORATORIES, CORP.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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