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Metrex Research Corp.

USA · Romulus

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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

12listed device types

Class I 8Class II 4Class III 0

plus 18 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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 II 2

4 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States18 registration records, 6 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: METREX RESEARCH · Metrex Research LLC · METREX RESEARCH LLC · METREX RESEARCH LLC, DBA ORASCOPTIC · METREX RESEARCH, LLC DBA ORASCOPTIC

FDA 510(k) clearances by year

31994 · K931052

21995 · K950553

11998 · K981023

FDA listed device types

showing 8 of 12

Cover, Barrier, Protective 1Indicator, Physical/Chemical Sterilization Process 1Sterilant, Medical Devices 1Drape, Surgical, Exempt 1Accessories, Cleaning Brushes, For Endoscope 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Accessory, Surgical Apparel 1Unit, Operative Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K981023	KLEENASEPTIC	1998-04-30
US	K950553	COLDCIDE-2	1995-03-22
US	K950516	COLDCIDE-10	1995-03-22
BR	10064010287	Lupas Orascoptic	Class I
CA	60913	DENTAL UNIT WATERLINE FILTER	Class II
CA	103422	METRICIDE	Class II

Metrex Research 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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