ME MEDICAL AG

Switzerland

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Israel — 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

8listed device types

Class I 7Class II 1Class III 0

plus 8 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

142registered devices

Class I 54Class II 88

229 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States8 registration records, 2 510(k), 0 PMA, 7 excluded

Brazil142 confirmed, 280 excluded

Saudi Arabia4 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: FAGA MEDICAL INDUSTRIA DE EQUIPAMENTOS E INSTRUMENTOS MEDICO HOSPITALARES LTDA ME · FAGA MEDICAL INDUSTRIA DE EQUIPAMENTOS E INSTRUMENTOS MEDICO-HOSPITALARES LTDA ME · Autentica Medical Importação Comercio e Serviços LTDA-ME · ENDOSCOPY MEDICAL SYSTEMS - ME · MIT MEDICAL INDUSTRY TECHNOLOGY LTDA - ME · ME Medical AG

Same-named companies — This database also contains companies with near-identical names: A. R. INDÚSTRIA E COMÉRCIO DE INSTRUMENTOS CIRÚRGICOS LTDA - ME, FAGA MEDICAL INDUSTRIA DE EQUIPAMENTOS E INSTRUMENTOS MEDICO HOSPITALARES LTDA ME. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12014 · K132735

12021 · K202577

FDA listed device types

Motor, Surgical Instrument, Ac-Powered 1Cannula, Ear 1Cannula, Surgical, General & Plastic Surgery 1Instrument, Manual, Surgical, General Use 1Snare, Surgical 1Tray, Surgical, Instrument 1Accessories, Catheter 1Bottle, Collection, Vacuum 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202577	Medical Surgical Mask-Model MP002-5, MP002-6	2021-01-11
US	K132735	AXIA RADIAL HEAD SYSTEM	2014-01-07
BR	80436220042	SISTEMA DE DRENAGEM DE FLUIDOS CORPORAIS FAGA MEDICAL	Class II
BR	80436220041	Sistema de Cânula Faga com Mandril 4,5 mm	Class I
BR	80436220040	SISTEMA PARA INTRODUÇÃO DE FIOS DE SUSTENTAÇÃO	Class I
SA	ME0000012813SFDAA00001	Professional Clipper	—
SA	ME0000012813SFDAA00002	Professional Clipper	—

ME MEDICAL AG

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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