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Maxtec, Inc.

USA · Salt Lake City

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 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

10510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

20 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

18active ARTG entries

Class I 4IIa 8IIb 6

HKHong KongMDACS

3valid listings

Class II 2Class III 1

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.

United States0 registration records, 10 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: MAXTEC, LLC · MAXTEC LLC. · MAXTEC INC. · Maxtec, LLC · Maxtec

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231895	Maxtec MaxBlend2+p	2023-12-04
US	K221734	Maxtec MaxO2 ME+p	2023-04-01
US	K182362	MaxCap Ped and MaxCap Neo	2019-05-23
BR	81447950013	Fluxômetro de Alto Fluxo	Class I
BR	80171530106	Misturador de Ar/O2 MaxFlo Mini	Class I
BR	10273829003	PROTETOR OCULAR EYEMAX	Class I
SA	ME0000006151SFDAA00001	EyeMax2	—
SA	ME0000016969SFDAA00001	Eyemax2	—
CA	62835	OXYGEN SENSOR	Class II
CA	82629	MAX OXYGEN SENSORS	Class II
CA	88491	MAXFLO2 (AIR/OXYGEN GAS MIXER)	Class II

Maxtec, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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