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Ito Co., Ltd.

Active in EUDAMED

Japanfrom SRN EUDAMED FDA SRN JP-MF-000021681 FEI 1000533128

Ito Co., Ltd. is a medical device manufacturer based in Japan, with 17 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II and Unclassified; EU Class IIa) as of 13 Nov 2026.

Devices
17
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 8
  • EUDAMED 6
  • FDA GUDID 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 10
  • EU Class IIa 5
  • FDA Unclassified 2
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN JP-MF-000021681
  • FDA FEI 1000533128
  • DUNS 690637194

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
MDSS GmbHDE

Catalogue17

Newest first, rows 1-17 of 17

Search and filter all 17 devices
Skip device list

  • D function

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Es-130

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:—

  • Tm-400

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Es-160

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Es-5200

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Us-101l, Us-103S Ref K112520

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trio 300 Ref K990787

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sw-180 Shortwave Therapy Unit Ref K022846

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tm-400 Ref K081247

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model Es-130 Ref K081943

    Active Regimes: CE MDD 510(k) Registry: 510(k) Class:—

  • D function Ref K203525

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Us-100 Portable Ultrasound Therapy Unit Ref K032793

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tm-300 Traction System Ref K992545

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Es-5400

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Eu-921

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Eu-941

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Us-751

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

Rows 1-17 of 17

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
JP-MF-000021681
FDA FEI number
1000533128
DUNS number
690637194
EU VAT number
IT09688660159
EUDAMED status
Active
EUDAMED registered name
ITO CO., LTD.
Registered address
3-1-8, Sakae-cho, 332-0017, Saitama, Japan
PRRC contact
Shinya Nishio(public in EUDAMED)

Frequently asked questions

How many devices does ITO CO., LTD. have in the registry?

The registry currently lists 17 devices for ITO CO., LTD.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ITO CO., LTD.'s devices?

Among its 17 most recently registered devices, ITO CO., LTD. has devices listed in EUDAMED (6 devices), FDA 510(k) (8 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do ITO CO., LTD.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for ITO CO., LTD.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from ITO CO., LTD. in the registry?

The most recently registered devices listed for ITO CO., LTD. include D function, ES-130, TM-400 and ES-160.

Generated automatically from registry data and not verified by a human reviewer.