HomeJapanKITAZATO CORPORATION

KITAZATO CORPORATION

Japan · Fuji
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
8listed device types
Class I 0Class II 8Class III 0
plus 32 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
33registered devices
Class I 20Class II 13
36 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
10 including historic records
TWTaiwanTFDA
9valid device licences
Class II 9
SGSingaporeHSA SMDR
5device registrations
CLASS B 3CLASS C 1CLASS D 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
7active ARTG entries
Class III 2IIa 3Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
8active registrations
Class 2a 6Class 2b 2
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 States32 registration records, 13 510(k), 0 PMA, 3 excluded
Brazil33 confirmed, 4 excluded
Manufacturer names merged into this page: KITAZATO CORPORATION · Kitazato Corporation

Company information

Country
Japan
City
Fuji

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Corporate Number
9010001108188
Registration status
Active
Registered capital
JPY 10,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

42017
22018 · K181469
12019 · K190199
42020 · K200249
12025 · K251305
12026 · K260248

FDA listed device types

Needle, Assisted Reproduction 1Catheter, Assisted Reproduction 1Media, Reproductive, Exempt 1Media, Reproductive 1Microtools, Assisted Reproduction (Pipettes), Exempt 1Tubing, Noninvasive 1Labware, Assisted Reproduction 1Labware, Assisted Reproduction, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260248Ultra-Fast Warm2026-04-28
USK251305Ultra-Fast Vitri; Ultra-Fast Warm2025-08-26
USK200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])2020-10-23
BR83014770001Cateter de Inseminação Intrauterina (IUI) KitazatoClass I
BR83014770002Cateter de Transferência Embrionária (ET) KitazatoClass I
BR83014779001Agulha de Aspiração de oócitos (OPU) KitazatoClass II

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