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Home›USA›Olympus Keymed (Medical & Industrial Equipment) LT

Olympus Keymed (Medical & Industrial Equipment) LT

USA · San Diego
✓ 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
8listed device types
Class I 3Class II 5Class III 0
plus 7 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
28registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
5active device licences
Class II 4Class III 1
17 including historic records
TWTaiwanTFDA
pendingnot queried
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 States7 registration records, 8 510(k), 0 PMA, 2 excluded
Saudi Arabia28 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: KEYMED (Medical & Industrial Equipment) Ltd · KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD. · KeyMed (Medical and Industrial Equipment) Ltd · KeyMed (Medical & Industrial Equipment) Ltd.
Same-named companies — This database also contains companies with near-identical names: Keymed (Medical and Industrial Equipment) , Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Diego

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

11988
11994
11996
12000
12001
12010
12013
12020

FDA listed device types

Accessories, Photographic, For Endoscope (Exclude Light Sources) 1Accessories, Cleaning Brushes, For Endoscope 1Endoscopic Bite Block 1Extractor, Vacuum, Fetal 1Endoscopic Access Overtube, Gastroenterology-Urology 1Endoscopic Irrigation/Suction System 1Pump, Air, Non-Manual, For Endoscope 1Pump, Portable, Aspiration (Manual Or Powered) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK193250Irrigation Tubing with CO2 or Air2020-04-06
USK122818OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE2013-01-04
USK100899OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-22010-09-13
SAME0000002797SFDAA00009TC C4 TROLLEY—
SAME0000002797SFDAA00010TC-C3 TROLLEY—
CA4898OLYMPUS KEYMED AUTO-DISINFECTOR 2Class II
CA12003ATKINSON ESOPHAGEAL PROSTHESISClass III
CA61483OLYMPUS ENDOSCOPIC SUCTION PUMPSClass II

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