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Whill, Inc.

Active in EUDAMED

Japanfrom SRN EUDAMED FDA SRN JP-MF-000016481 FEI 3021071770

Whill, Inc. is a medical device manufacturer based in Japan, with 11 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I; FDA Class II) and 2 FDA recalls as of 15 Nov 2026.

Devices
11
Registrations
EUDAMEDFDA
FDA recalls
22 ongoing

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 6
  • FDA GUDID 4
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • EU Class I 6
  • FDA Class II 5
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN JP-MF-000016481
  • FDA FEI 3021071770
  • DUNS 691746455

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
CMC Medical Devices & Drugs SLES

Catalogue11

Newest first, rows 1-11 of 11

Search and filter all 11 devices
Skip device list

  • WHILL (WHILL Model C2) Ref K261175

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

  • WHILL Model R 4-wheel Ref 32-21014-1-03-2025-02-28

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • WHILL, Inc. Model C2 Open recall

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

  • WHILL, Inc. Model C2 Open recall

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

  • WHILL Model M

    Withdrawn Registry: GUDID Class:II

  • WHILL Model C Lite Ref 32-15018-1-01-2026-03-06

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • WHILL Model F Ref 32-14016-1-04-2024-02-15

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • WHILL Model M Ref K153543

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

  • WHILL Model R 3-wheel Ref 32-21014-1-03-2025-02-28

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:I

  • WHILL Autonomous Model B Ref 32-18010-0-01-2024-07-15

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • WHILL Model C2 Ref 32-00022-J-02-2024-02-15 Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:I

Rows 1-11 of 11

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
JP-MF-000016481
FDA FEI number
3021071770
DUNS number
691746455
EUDAMED status
Active
EUDAMED registered name
WHILL, Inc.
Registered address
2-1-11 Higashishinagawa, Shinagawa-ku, 140-0002, Tokyo, Japan
PRRC contact
Tsuyoshi Iriyama(public in EUDAMED)

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 2
  • 2026 0

  • 2025

    • 29 Dec 2025 Z-1826-2026 Class I Ongoing Cyber vulnerability of BLE communication was found by CISA VDP program. Distribution: US: Kansas Submission number: K213383
    • 29 Dec 2025 Z-1827-2026 Class I Ongoing Cyber vulnerability of BLE communication was found by CISA VDP program. Distribution: US: Kansas Submission number: K221438

Frequently asked questions

How many devices does WHILL, INC. have in the registry?

The registry currently lists 11 devices for WHILL, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list WHILL, INC.'s devices?

Among its 11 most recently registered devices, WHILL, INC. has devices listed in EUDAMED (6 devices), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do WHILL, INC.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for WHILL, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for WHILL, INC.?

FDA recall records list 2 recalls initiated by WHILL, INC., the most recent initiated on 29 Dec 2025. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from WHILL, INC. in the registry?

The most recently registered devices listed for WHILL, INC. include WHILL (WHILL Model C2), WHILL Model R 4-wheel, WHILL, Inc. Model C2 and WHILL Model M.

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