HomeJapanDAIKEN MEDICAL CO., LTD.

DAIKEN MEDICAL CO., LTD.

Japan · Osaka · www.daiken-iki.co.jp
✓ Record-verifiedregistrations found in 6 marketsEU SRN JP-MF-000019611

This company has registrations in European Union, United States, Brazil, Taiwan, Singapore, South Korea — 6 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
6UDI-DI device records
Class I 6
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
7registered devices
Class II 7
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
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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.

European Union6 raw hits, 0 excluded, 6 confirmed
United States0 registration records, 2 510(k), 0 PMA
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: DAIKEN MEDICAL CO. LTD · DAIKEN MEDICAL CO. LTD.

Regulatory identity

EU manufacturer SRN
JP-MF-000019611
EU authorised representative
Medical Technology Promedt Consulting GmbH

Company information

Country
Japan
City
Osaka
Website
www.daiken-iki.co.jp
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instrumentsAnaesthesia, intensive care & life-support systems

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

Legal name
DAIKEN MEDICAL CO.,LTD
Corporate Number
7120001083307
Registration status
Active
Registered capital
JPY 495,000,000

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

12008 · K071694
12010 · K093888

Registration details (sample)

MarketIdentifierNameClass / date
EU24571106022819Class I
EU04571106021955Class I
EU04571106021986Class I
EU04571106021979Class I
USK093888COOPDECH ENDOBRONCHIAL BLOCKER TUBE2010-03-16
USK071694COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX2008-03-20
BR80400320003Fit Fix® CoopdechClass II
BR80400320004QIN POT® COOPDECHClass II
BR80400329002Bolsa Coletora para dispositivo de drenagem por sucção Qin Pot® CoopdeClass II

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