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BIOMETRIX LIMITED

Slovakia · Samorin Bratislavsky

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Russia — 6 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

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

64registered devices

Class I 9Class II 55

67 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

5active registrations

Class 1 1Class 2a 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 States2 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil64 confirmed, 1 excluded

Manufacturer names merged into this page: Biometrix sro · BIOMETRIX LTD. · BIOMETRIX LTD · BIOMETRIX LIMITED · Biometrix.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151040	Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer	2015-09-04
US	K011216	PVC FREE INTRAVASCULAR ADMINISTRATION SET	2001-07-18
US	K001461	TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET	2000-09-11
BR	10332200070	GUIA BIOMETRIX	Class II
BR	10332200073	SUPORTE ORGANIZADOR	Class I
BR	10332200072	CABO ADAPTADOR PARA TRANSDUTOR	Class I

BIOMETRIX LIMITED

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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