HomeJapanTerumo Corporation

Terumo Corporation

Japan · Hatagaya Shibuya-Ku
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, 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
pendingnot queried
USUnited StatesFDA openFDA
29listed device types
Class I 2Class II 25Class III 2
plus 69 registration records and 34 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
36registered devices
Class I 6Class II 30
66 including historic records
SASaudi ArabiaSFDA
9registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
37active device licences
Class II 25Class III 11Class IV 1
75 including historic records
TWTaiwanTFDA
9valid device licences
Class I 2Class II 5Class III 2
SGSingaporeHSA SMDR
53device registrations
CLASS B 25CLASS C 14CLASS D 14
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
36active ARTG entries
Class I 6Class III 12IIa 12IIb 4Class Is (sterile) 2
HKHong KongMDACS
32valid listings
Class II 11Class III 3Class IV 18
ILIsraelAMAR
35registrations
RURussiaRoszdravnadzor
35active registrations
Class 1 2Class 2a 5Class 2b 6Class 3 22
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 States69 registration records, 34 510(k), 0 PMA, 46 excluded
Brazil36 confirmed, 15 excluded
Saudi Arabia9 confirmed, 1 excluded
Canada37 confirmed, 11 excluded
Manufacturer names merged into this page: TERUMO CORP. · TERUMO CORPORATION · Terumo Corporation

Company information

Country
Japan
City
Hatagaya Shibuya-Ku

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

Corporate Number
3011001015116
Registration status
Active
Registered capital
JPY 38,716,000,000

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

21991
11995
21998
22000
12002
32003
22004
32007
12008
32009
12010
22012
22013
12017
22018
12019
22024
22025
12026

FDA listed device types

showing 8 of 29
Heat-Exchanger, Cardiopulmonary Bypass 1Endoscopic Guidewire, Gastroenterology-Urology 1Needle, Hypodermic, Single Lumen 1Catheter, Intravascular, Diagnostic 1Detector, Bubble, Cardiopulmonary Bypass 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Laparoscope, General & Plastic Surgery 1Clamp, Vascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252295Ryurei2026-03-27
USK250700Pen Injector Needle 32.52025-11-21
USK250751DualView Catheter2025-07-17
BR80012280018SERINGA SEM AGULHA TERUMOClass II
BR80012280023AGULHA GENGIVAL TERUMOClass II
BR80012280158Surflo® Dispositivo com Asas para Infusão Terumo®Class II
SAME0000000974SFDAA00367CAPIOX CABLE
SAME0000000974SFDAA00369CAPIOX SX HOLDER
CA9028TERUFUSION PLASMA TRANSFER SETClass II
CA93193IMUGARD III S-PLClass II
CA1136RADIFOCUS ANGIOGRAPHIC CATHETERClass II

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