HomeJapanMACHIDA ENDOSCOPE CO., LTD.

MACHIDA ENDOSCOPE CO., LTD.

Japan · Abiko Chiba
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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
3listed device types
Class I 1Class II 2Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 1Class II 6
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 2Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class I 8
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States3 registration records, 1 510(k), 0 PMA, 2 excluded
Brazil7 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: MACHIDA ENDOSCOPE CO., LTD. · MACHIDA ENDOSCOPE CO. LTD. · Machida Endoscope Co., Ltd.

Company information

Country
Japan
City
Abiko Chiba

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 510(k) clearances by year

12000 · K993568

FDA listed device types

Laryngoscope, Nasopharyngoscope 1Led Light Source 1Laryngoscope, Rigid 1

Registration details (sample)

MarketIdentifierNameClass / date
USK993568MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L2000-03-13
BR80088370042Broncofibroscópio Flexível MachidaClass II
BR80088379007Vídeo Nasofaringo-laringoscópio Flexível ENT-30VEClass II
BR80088379008Processadora de Imagem VSP-2000Class II
SAME0000004684SFDAA00002Portable LED Light Source RLED-30
SAME0000004684SFDAA00001Flexible Nasopharyngo Laryngoscope

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