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VIOL Co., Ltd.

South KoreaFDA applicant, unverified FDA FEI 3009206941

VIOL Co., Ltd. is a medical device manufacturer, with 22 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II) as of 14 Nov 2026.

Devices
22
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 18
  • FDA 510(k) 4
  • EUDAMED 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 22
Sites and related companies
Identifiers
  • FDA FEI 3009206941
  • DUNS 695654949

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI
Authorised rep.
AR Experts B.V.NL

What VIOL Co., Ltd. makes

VIOL Co., Ltd. manufactures electrosurgical systems, endoscopic electrosurgical handpieces and electrodes (bipolar, single-use), and electrical foot-switches. Specific products include the CELLINEW electrosurgical system, SCARLET SRF, and various consumable tips and handpieces such as XA25, XW18, and CELLINEW TIP.

The company's devices are classified as Class II and Class IIb and are listed in regulatory registries including Eudamed, FDA 510(k), and FDA UDI.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue22

Newest first, rows 1-22 of 22

Search and filter all 22 devices
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  • Scarlet Pro (Scarlet Pro) Ref K253859

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

  • Cellinew

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

  • Foot Switch F/S-Hrf-Blue

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

  • Scarlet Srf

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

  • CELLINEW Foot switch

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

  • Foot Switch F/S

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

  • Consumable Tip

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

  • XA25 J25BS

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Cellinew Tip CE25

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

  • XW18 J18BS

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Hand Piece H/S_02

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

  • Cellinew Tip CF40

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

  • Consumable Tip

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

  • Foot switch F/S-B

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

  • Celfirm

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

  • Scarlet Pro

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Hand Piece H/S_03

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

  • CELLINEW Handpiece

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

  • Handpiece P/B

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

  • Scarlet Srf Ref K180872

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

  • Cellinew Ref K240897

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

  • Celfirm Ref K172023

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

Rows 1-22 of 22

Company details

FDA FEI number
3009206941
DUNS number
695654949
Address
C-209-1, 802~809, Bundang Technopark C, Seongnam-si Gyeonggi

Frequently asked questions

How many devices does VIOL Co., Ltd. have in the registry?

The registry currently lists 22 devices for VIOL Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list VIOL Co., Ltd.'s devices?

Among its 22 most recently registered devices, VIOL Co., Ltd. has devices listed in EUDAMED (3 devices), FDA 510(k) (4 devices) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do VIOL Co., Ltd.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for VIOL Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from VIOL Co., Ltd. in the registry?

The most recently registered devices listed for VIOL Co., Ltd. include Scarlet Pro (Scarlet Pro), CELLINEW, FOOT SWITCH F/S-HRF-BLUE and SCARLET SRF.

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