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Terumo Corp.

US

Last updated May 23, 2026

What Terumo Corp. makes

Terumo Corp. makes a range of medical devices, including guidewires, angiographic catheters, vascular guide-catheters, peripheral artery stents, vascular microcatheters, and extracorporeal membrane oxygenators. These devices are used in various medical procedures, such as cardiac and peripheral vascular interventions. The company's portfolio also includes gastro-urological guidewires and general-purpose non-vascular guidewires.

The company's devices are regulated under Class I, Class II, and Class III classifications and are listed in the FDA's UDI registry. Terumo Corp. is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of medical devices does Terumo Corp. manufacture?

Terumo Corp. makes guidewires, catheters, stents, and oxygenators, which are used in cardiac, vascular, and other medical procedures, because these devices are listed in the company's device categories.

Where is Terumo Corp. based?

Terumo Corp. is based in the US, as indicated by the company's country listing.

Which regulatory registry lists Terumo Corp.'s devices?

Terumo Corp.'s devices are listed in the FDA's UDI registry, which tracks unique device identifiers for medical devices.

How are Terumo Corp.'s devices classified?

Terumo Corp.'s devices are classified under Class I, Class II, and Class III, which are regulatory classifications that determine the level of control and oversight for medical devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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Catalogue (676)

Page 14 of 14
DeviceModel / ReferenceRegistriesClassStatus
Capiox Sp Pump Head K943861
FDA 510(k)
Class IIActive
Surshield Safety Winged Infusion Set K031266
FDA 510(k)
Class IIActive
Heartrail Iii Guiding Catheter K113335
FDA 510(k)
Class IIActive
Immucise Intradermal Injection System K181369
FDA 510(k)
Class IIActive
NaviCross 0.018 K173799
FDA 510(k)
Class IIActive
DualView Catheter K250751
FDA 510(k)
Class IIActive
Capiox Circuit Connectors K073474
FDA 510(k)
Class IIActive
Ryurei K252295
FDA 510(k)
Class IIActive
Glidewire GT K170417
FDA 510(k)
Class IIActive
Capiox Rx05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir K022115
FDA 510(k)
Class IIActive
Immucise K190427
FDA 510(k)
Class IIActive
Heartrail Iii Guiding Catheter K092372
FDA 510(k)
Class IIActive
Capiox Rx05 Hollow Fiber Oxygenator/Reservoir K130493
FDA 510(k)
Class IIActive
Terumo Venoject, Luer Adapter K983490
FDA 510(k)
Class IIActive
Capiox Fx Hollow Fiber Oxygenator W/ Reservoir K130280
FDA 510(k)
Class IIActive
Capiox Fx05 Hollow Fiber Oxygenator With Integrated Arterial Filter K071572
FDA 510(k)
Class IIActive
Pump Tubing With X-Coating K003371
FDA 510(k)
Class IIActive
Terumo Surflash Safety I.v. Catheter K122544
FDA 510(k)
Class IIActive
R2P Radifocus Glidewire Advantage K240818
FDA 510(k)
Class IIActive
Terumo Allergy Syringe K980796
FDA 510(k)
Class IIActive
Torque Device For A Guide Wire K910969
FDA 510(k)
Class IIActive
Terumo Surshield- Pur Safety I.v. Catheter K100282
FDA 510(k)
Class IIActive
Glidewire GT-R K240859
FDA 510(k)
Class IIActive
Modification To Capiox Sx10 Hardshell Reservoir K030449
FDA 510(k)
Class IIActive
450cm Guide Wire For G.i. Use K910722
FDA 510(k)
Class IIActive
Capiox Rx25 Hollow Fiber Oxygenator W/Wo Hardshell Reservoir K040210
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Terumo Corp. SHIBUYA-KU, TOKYO · JP FEI 2828