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Home›Japan›HOYA Corporation PENTAX Lifecare Division

HOYA Corporation PENTAX Lifecare Division

Japan · Kurihara-Shi Miyagi
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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
31listed device types
Class I 8Class II 23Class III 0
plus 154 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
2 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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.

United States154 registration records, 2 510(k), 0 PMA, 10 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia2 confirmed, 1 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: HOYA Corporation PENTAX Lifecare Division · PENTAX MEDICAL, A DIVISION OF PENTAX OF AMERICA, INC · PENTAX MEDICAL COMPANY, a Division of PENTAX of America, Inc

Company information

Country
Japan
City
Kurihara-Shi Miyagi

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

22019 · K193036

FDA listed device types

showing 8 of 31
Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Esophagoscope (Flexible Or Rigid) 1Endoscope Channel Accessory 1Light Source, Endoscope, Xenon Arc 1Nasopharyngoscope (Flexible Or Rigid) 1Forceps, Biopsy, Electric 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1

Registration details (sample)

MarketIdentifierNameClass / date
USK193036C2 CryoBalloon EndoGrip2019-11-22
USK190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge2019-05-31
SAME0000004826SFDAA00011Pentax Laryngostroboscope—
SAME0000004826SFDAA00010`PENTAX Adaptor—

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