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Haemonetics Corporation

USA · Boston

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

15listed device types

Class I 3Class II 11Class III 0unclassified 1

plus 77 registration records and 36 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 3Class II 6

30 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

28active device licences

Class II 24Class III 4

40 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

16device registrations

CLASS B 5CLASS C 11

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

24active ARTG entries

IVD Class 1 2IVD Class 2 7IIa 6IIb 9

HKHong KongMDACS

10valid listings

Class II 2Class III 7IVD C 1

ILIsraelAMAR

28registrations

RURussiaRoszdravnadzor

19active registrations

Class 1 1Class 2a 5Class 2b 9Class 3 4

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 States77 registration records, 36 510(k), 0 PMA, 2 excluded

Brazil9 confirmed, 1 excluded

Canada28 confirmed, 2 excluded

Manufacturer names merged into this page: Haemonetics Corporation · HAEMONETICS CORPORATION · HAEMONETICS SA

Business registration

Legal name: HAEMONETICS CORP
CIK: 0000313143
Registration status: Active
Listing status: Listed (HAE)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

21985

11986

21988

11989

21990

11994

11995

11996

11999

12002

32005

22006

12010

22012

12016

22017

12019

12022

12024

22025

FDA listed device types

showing 8 of 15

Activated Whole Blood Clotting Time 1Separator, Automated, Blood Cell, Diagnostic 1Blood Establishment Computer Software And Accessories 1System, Processing For Frozen Blood 1System, Multipurpose For In Vitro Coagulation Studies 1Plasma, Coagulation Control 1System, Automated Platelet Aggregation 1Pump, Infusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	2025-04-30
US	K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	2025-01-15
US	K232018	Citrated: K, KH, RTH, FFH	2024-03-29
BR	10234400160	Tromboelastógrafo TEG - Haemonetics	Class II
BR	10234409045	Frasco para coleta de plasma para uso com o Sistema NexSys PCS®	Class II
BR	10234409043	Bowl para separação de hemocomponentes	Class II
CA	737	HAEMONETICS 115 CELL WASH SYSTEM	Class II
CA	1049	CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM	Class II
CA	1640	CELL SAVER 3 AUTOLOGOUS BLOOD RECOVERY SYSTEM	Class II