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Fujifilm Irvine Scientific, Inc.

USA · Santa Ana

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Russia — 5 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

4listed device types

Class I 2Class II 2Class III 0

plus 22 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

23 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

15 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States22 registration records, 21 510(k), 0 PMA, 9 excluded

Brazil2 confirmed, 6 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: IRVINE SCIENTIFIC LLC · IRVINE SCIENTIFIC, LLC · FUJIFILM IRVINE SCIENTIFIC, INC

Same-named companies — This database also contains companies with near-identical names: IRVINE SCIENTIFIC, LLC, Irvine Scientific Sales Co., Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

41982

11985

51987

11988

21989

11990

11994

12016

12019

12023

22024

12025

FDA listed device types

Kit, Culture, Chromosome 1Media And Components, Synthetic Cell And Tissue Culture 1Media, Reproductive 1Labware, Assisted Reproduction 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250445	Fast Warm - NX	2025-09-12
US	K241341	cryo-GO Vitrification Device	2024-09-26
US	K233764	SSS-NX (Serum Substitute Supplement-NX)	2024-04-24
BR	10318390011	MEIO DE CULTURA POLYVINYLPYRROLIDONE	Class I
BR	10318390019	9305 OLEO MINERAL PARA CULTURA DE EMBRIOES	Class II

Fujifilm Irvine Scientific, 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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