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Research Medical, Inc.

USA · Midvale

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

47listed device types

Class I 12Class II 35Class III 0

plus 148 registration records and 202 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

23registered devices

Class I 8Class II 15

24 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

20active device licences

Class II 20

49 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States148 registration records, 202 510(k), 1 PMA, 344 excluded

Brazil23 confirmed, 21 excluded

Saudi Arabia1 confirmed, 10 excluded

Canada20 confirmed, 35 excluded

Manufacturer names merged into this page: ADVANCED RESEARCH MEDICAL · FUJIFILM Corporation Medical Systems Research & Development Center Kaisei · FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji · FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama · MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. · MEDICAL RESEARCH LOBORATORIES, INC. A WELCH ALLYN COMPANY

FDA 510(k) clearances by year

32000

42001

42002

32003

12004

32005

42006

42007

52008

62009

22010

52011

42012

12013

12015

22016

12017

42018

22021

12023

FDA listed device types

showing 8 of 47

Endoscopic Access Overtube, Gastroenterology-Urology 1Intervertebral Fusion Device With Bone Graft, Lumbar 1System, X-Ray, Tomography, Computed 1System, Nuclear Magnetic Resonance Spectroscopic 1Oximeter 1Laparoscope, General & Plastic Surgery 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1Coil, Magnetic Resonance, Specialty 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230501	Spirobank Oxi	2023-12-15
US	K203513	SLENDERTONE Evolve Abs, Type 735	2021-02-10
US	K203373	Advanced Research Medical Trident SI Screw System	2021-01-22
BR	80160400033	CATETER DE HISTEROSALPINGOGRAFIA	Class II
BR	80022069067	Vídeoendoscópio	Class II
BR	10317490199	SU-1 PROCESSADOR DE ULTRASSONS	Class II
SA	ME0000004167SFDAA00020	Gammaprobe Surgical Explorer	—
CA	75455	NEUROTECH OMNITENS XP	Class II
CA	75814	NT TENS DETACHABLE LEADS	Class II
CA	76052	NEUROTECH AVIVATENS XP	Class II

Research Medical, 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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