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Hamilton Thorne Biosciences

USA · Beverly

✓ Record-verifiedregistrations found in 4 markets

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

18listed device types

Class I 3Class II 14Class III 0unclassified 1

plus 28 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States28 registration records, 14 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: HAMILTON THORNE, Inc. · HAMILTON THORNE, INC. · Hamilton Thorne, Inc · HAMILTON THORNE INC.

Same-named companies — This database also contains companies with near-identical names: Hamilton Thorne Incorporated, Hamilton Thorne Research. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11987

11992

11999

12000

12002

12004

12005

12007

12012

22019

22020

12021

FDA listed device types

showing 8 of 18

Counter, Differential Cell 1Catheter, Assisted Reproduction 1Media, Reproductive, Exempt 1Media, Reproductive 1Accessory, Assisted Reproduction, Exempt 1Microtools, Assisted Reproduction (Pipettes), Exempt 1Semen Analysis Device 1Material, Quality Control, Semen Analysis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202241	LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)	2021-07-02
US	K192503	GM501 Wash with Phenol Red and Gentamicin	2020-11-19
US	K192644	GM501 SpermAir and GM501 SpermActive	2020-04-23
BR	10318390109	Sistema de Laser para Reprodução Assistida	Class II
BR	10318390111	FAMÍLIA DE INSTRUMENTOS PARA ANÁLISE DE SÊMEM	Class II
CA	88958	ASSISTED REPRODUCTION LASER SYSTEMS	Class II

Hamilton Thorne Biosciences

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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