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Fuji Systems Corporation, Shirakawa Plant

Active in EUDAMED

Japanfrom SRN EUDAMED FDA SRN JP-MF-000006591 FEI 3000308637

Devices
25
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

3 of 3 in force.

See certificates

Market reach

European Union
EUDAMED actor, 3 certificates
United States
FDA FEI

Catalogue25

Newest first, rows 1-25 of 25

Search and filter all 25 devices
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  • Univent Tube Ref 1302930

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Univent Tube Ref 1302933

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Sp-Gripflow Ref 1182216

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sp-Gripflow Ref 1182212

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Univent Tube Ref 1302935

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Univent Tube Ref 1302937

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Univent Tube Ref 1302939

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Left Lung) Ref 1303535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Right Lung) Ref 1303635

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Sp-Gripflow Ref 1182316

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Univent Tube Ref 1302928

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Left Lung) Ref 1303533

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Left Lung) Ref 1303537

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Sp-Gripflow Ref 1182214

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sp-Gripflow Ref 1182312

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Uniblocker Ref 1303104

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Sp-Gripflow Ref 1182314

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Univent Tube Ref 1302927

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uniblocker Ref 1303105

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Univent Tube Ref 1302931

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Right Lung) Ref 1303637

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Right Lung) Ref 1303633

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Left Lung) Ref 1303539

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Silbroncho (Right Lung) Ref 1303639

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Univent Tube Ref 1302936

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 1-25 of 25

Company details

EUDAMED SRN
JP-MF-000006591
FDA FEI number
3000308637
EU VAT number
4010001119826
EUDAMED status
Active
EUDAMED registered name
Fuji Systems Corporation, Shirakawa Plant
Registered address
200-2 Aza-Ohira, Odakura, Nishigo,, 961-8061, Nishi Shirakawa Gun, Fukushima, Japan
Phone
＋81356891913
PRRC contact
Katsumi Sone(public in EUDAMED)

EUDAMED certificates3

3 certificates3 valid, 0 expiredMDR 3next expiry 1 Dec 2027

EUDAMED certificates (3)

BSI Group The Netherlands B.V. 2797 3 certificates

  • MDR 810807 Active

    Technical documentation EU MDR

    Issued
    14 May 2026
    Expires
    13 May 2031
  • MDR 784870 Active Supplemented

    Quality management system EU MDR

    Issued
    14 May 2026
    Expires
    23 Jul 2029
    Reason
    Add device or group
  • MDR 746323 Active Amended

    Quality assurance EU MDR

    Issued
    31 Mar 2026
    Expires
    1 Dec 2027
    Reason
    Mnf data change

From the company website

Read 18 Oct 2026

富士システムズ株式会社はカテーテルをはじめとするシリコーン素材を使った医療機器開発の世界的パイオニア企業。これまで培ってきたシリコーンへの知見や、医療機器開発のノウハウを活かし、ライフサイエンス分野での研究・開発にも積極的に取り組んでいきます。

From the manufacturer's own website, in their original language. Source

Frequently asked questions

How many devices does Fuji Systems Corporation, Shirakawa Plant have in the registry?

The registry currently lists 25 devices for Fuji Systems Corporation, Shirakawa Plant. Devices recorded under merged duplicate company entries are counted once.

Which registries list Fuji Systems Corporation, Shirakawa Plant's devices?

Among its 25 most recently registered devices, Fuji Systems Corporation, Shirakawa Plant has devices listed in EUDAMED (25 devices).

What risk classes do Fuji Systems Corporation, Shirakawa Plant's devices fall under?

Among its 25 most recently registered devices, the classes recorded for Fuji Systems Corporation, Shirakawa Plant's devices are Class IIa and Class III. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Fuji Systems Corporation, Shirakawa Plant?

EUDAMED lists 3 certificates for Fuji Systems Corporation, Shirakawa Plant (technical documentation; quality management system; quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 14 May 2026.

What are the newest devices from Fuji Systems Corporation, Shirakawa Plant in the registry?

The most recently registered devices listed for Fuji Systems Corporation, Shirakawa Plant include UNIVENT TUBE, SP-GRIPFLOW, SILBRONCHO (LEFT LUNG) and SILBRONCHO (RIGHT LUNG).

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