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Com-Med International, Inc.

USA · Grayslake

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

24registered devices

Class I 14Class II 10

32 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

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, 31 excluded

Brazil24 confirmed, 58 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada3 confirmed, 3 excluded

Manufacturer names merged into this page: ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT. · MED.E.COM TRADING AS MEDECOM · GN INJECTA IND. E COM. MAT. MÉD. CIR. ODONT. E DESCART. LTDA · FRADEL-MED IND E COM DE APARELHOS MEDICOS LTDA-ME · LINE LIFE CARDIOVASCULAR COM DE PROD MED E HOSP LTDA · HELMEYSTER IND COM PRODS MED HOSP CORRELATOS LTDA

FDA 510(k) clearances by year

11983 · K830324

12000 · K002691

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	K002691	COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE	2000-12-08
US	K830324	AIRCARE 300	1983-03-10
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
CA	90002	GAMME DE LOGICIELS: MEDWS	Class II
CA	90177	LOGICIEL MEDMAMMO	Class II
CA	94399	MEDXRAY	Class II

Com-Med International, 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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