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Home›Japan›Kai Industries Co., Ltd.

Kai Industries Co., Ltd.

Japan · Seki City Gifu · www.kai-group.com
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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
0UDI-DI device records
USUnited StatesFDA openFDA
9listed device types
Class I 9Class II 0Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class IIa 3
BRBrazilANVISA
8registered devices
Class II 8
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
5device registrations
CLASS B 5
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
5active ARTG entries
IIa 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
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.

European Union5,567 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States9 registration records, 0 510(k), 0 PMA, 9 excluded
United Kingdom3 confirmed, 19 excluded
Brazil8 confirmed, 1 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: KAI INDUSTRIES CO., LTD. · KAI INDUSTRIES CO.,LTD · Kai industries co., ltd.

Regulatory identity

UK responsible person
Albert Waeschle Ltd

Company information

Country
Japan
City
Seki City Gifu
Website
www.kai-group.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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.

FDA listed device types

showing 8 of 9
Knife, Ophthalmic 1Scissors, General, Surgical 1Instrument, Manual, Surgical, General Use 1Scalpel, One-Piece 1Handle, Scalpel 1Blade, Scalpel 1Punch, Surgical 1Curette, Surgical, General Use 1

Registration details (sample)

MarketIdentifierNameClass / date
UK63259KaiClass IIa
UK46741KaiClass IIa
UK63166Kai Class IIa
BR80148319004MIcrolâmina de incisão com proteçãoClass II
BR80148319001Microlâmina de IncisãoClass II
BR10150470561Punch para Biópsia com botão KaiClass II
SAME0000009710SFDAA00001PREP RAZOR - DOUBLE EDGE PREP RAZOR - SINGLE EDGE—
SAME0000011753SFDAA00001PREP RAZOR—

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