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BIOTEK® INSTRUMENTS, INC.

USA · Winooski

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Israel, Russia — 4 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

37510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 37 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

9active registrations

Class 2a 9

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, 37 510(k), 0 PMA, 46 excluded

Brazil5 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: BIOTEK INSTRUMENTS, INC · BIOTEK® INSTRUMENTS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K973609	IDA-4 AND IPT-MC	1997-12-18
US	K971273	INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF	1997-10-08
US	K961862	MODELS IDA-2 PLUS AND IPT-1	1997-02-26
BR	10200510097	LEITORA MULTIDETECÇÃO - SYNERGY	Class II
BR	10339840216	LEITORA AUTOMATICA DE MICROPLACAS	Class II
BR	10200510092	LAVADORA DE MICROPLACAS E TIRAS	Class I

BIOTEK® INSTRUMENTS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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