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HEALTH MED IND E COMERCIO DE ARTIGOS HOSPITALARES LTDA ME

Brazil

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

17listed device types

Class I 14Class II 3Class III 0

plus 17 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

52registered devices

Class I 29Class II 23

55 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States17 registration records, 2 510(k), 0 PMA, 53 excluded

Brazil52 confirmed, 56 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT. · GN INJECTA IND. E COM. MAT. MÉD. CIR. ODONT. E DESCART. LTDA · FRADEL-MED IND E COM DE APARELHOS MEDICOS LTDA-ME · ANDRADE GOMES IND COM ARTEFATOS PLASTICOS LTDA-ME · HELMEYSTER IND COM PRODS MED HOSP CORRELATOS LTDA

Same-named companies — This database also contains companies with near-identical names: ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11980 · K803177

11983 · K823903

FDA listed device types

showing 8 of 17

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Activator, Ultraviolet, For Polymerization 1Bracket, Ceramic, Orthodontic 1Spring, Orthodontic 1Pusher, Band, Orthodontic 1Bur, Dental 1Instruments, Dental Hand 1Positioner, Tooth, Preformed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K823903	RUBBER INFLATABLE RING	1983-01-14
US	K803177	MOIST HEAT PACK	1980-12-31
BR	10223060002	CAPA DESCARTAVEL PARA SERINGA TRIPLICE - ARK PLAS	Class I
BR	10223060053	LIXAS ABRASIVAS DE AÇO INOXIDÁVEL INJECTA	Class I
BR	10223060038	TIRA DE LIXA DE POLIÉSTER - INJECTA	Class II

HEALTH MED IND E COMERCIO DE ARTIGOS HOSPITALARES LTDA ME

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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