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Medtek Devices, Inc.

USA · Buffalo

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

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

1active ARTG entries

IIb 1

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.

Australia: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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, 2 510(k), 0 PMA, 10 excluded

Brazil3 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BUFFALO FILTER, DIV OF MEDTEK DEVICES INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103375	PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL	2011-03-16
US	K052797	LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM	2006-02-13
BR	80037529006	ASPIRADOR DE FUMAÇA PARA LAPAROSCOPIA	Class I
BR	80744760001	BUFFALO FILTER - ASPIRADOR DE VAPOR E FUMAÇA CIRÚRGICA	Class I
BR	80744760002	ASPIRADOR DE FUMAÇA PARA LAPAROSCOPIA	Class I

Medtek Devices, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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