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Clarus Medical LLC

USA · Plymouth MN · www.clarus-medical.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN US-MF-000025783

This company has registrations in European Union, United States, Brazil, Canada, Australia, Israel — 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

6UDI-DI device records

Class I 6

USUnited StatesFDA openFDA

12listed device types

Class I 4Class II 8Class III 0

plus 17 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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.

European Union6 raw hits, 0 excluded, 6 confirmed

United States17 registration records, 32 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: CLARUS MEDICAL, LLC. · CLARUS MEDICAL, LLC

Regulatory identity

EU manufacturer SRN: US-MF-000025783
EU authorised representative: MPS Medical Product Service GmbH

FDA 510(k) clearances by year

21992

51993

31994

51995

31996

21997

21998

12001

22002

22004

12009

12021

12023

12024

12026

FDA listed device types

showing 8 of 12

Light Source, Endoscope, Xenon Arc 1Nasopharyngoscope (Flexible Or Rigid) 1Lamp, Endoscope, Incandescent 1Arthroscope 1Endoscope, Neurological 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Tube, Tracheal (W/Wo Connector) 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	10810004820620	Clarus Digital Inspection Scope, 2mm x 200cm	Class I
EU	10810004820637	Clarus Digital Inspection Scope, 2mm x 110cm	Class I
EU	10810004821009	Clarus Digital Inspection Scope, 2mm x 60cm	Class I
EU	10810004820644	Clarus Digital Inspection Scope, 1mm x 110cm	Class I
US	K252790	Digital ClarusScope System and Digital NeuroPEN System	2026-05-26
US	K240535	Digital ClarusScope System; Digital NeuroPEN System	2024-04-25
US	K223615	Digital ClarusScope System, Digital NeuroPEN System	2023-11-21
BR	80109170026	Kit de Cânulas Nucleotome Lombar	Class II
BR	10299940010	ENDOSCOPIO - OROLARINGOFIBROSCOPIO DE FIBRA OPTICA	Class II
BR	80109170027	Kit de Cânulas Nucleotome Cervical	Class II

Clarus Medical LLC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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