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Hemocue, Inc.

Sweden · Angelholm

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, 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

4listed device types

Class I 0Class II 4Class III 0

plus 10 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 4Class II 12

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

2active device licences

Class III 2

14 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 1IVD Class 2 2IVD Class 3 1

HKHong KongMDACS

4valid listings

IVD C 4

ILIsraelAMAR

5registrations

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 States10 registration records, 15 510(k), 0 PMA

Brazil16 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: HEMOCUE AB · HEMOCUE AB

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201217	HemoCue Hb 301 System	2020-08-04
US	K181751	HemoCue Hb 801 System	2019-02-01
US	K071652	HEMOCUE WBC SYSTEM	2007-10-25
BR	10033121089	HemoCue Hb 801 Microcuvettes	Class I
BR	10033121088	HemoCue Hb 801 Analyzer	Class II
BR	10033120921	HemoCue Hb 301 Microcuvettes	Class I
CA	72252	HEMOCUE DONOR HB CHECKER SYSTEM	Class III
CA	77189	HEMOCUE ALBUMIN 201 ANALYZER SYSTEM	Class III

Hemocue, Inc.

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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