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Scarlet Pro

by VIOL Co., Ltd.

Ref SCARLET PRO

Scarlet Pro is an electrosurgical system (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by VIOL Co., Ltd., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 880950233VIOLHFSUSCPUR), cleared under FDA 510(k) K180872 on 11 Oct 2018 and listed in FDA GUDID since 11 Jul 2025 (UDI-DI 08809502330422), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180872

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880950233VIOLHFSUSCPUR Basic UDI-DI 08809502330422UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809502330422 UDI-DI Date11 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180872 Date11 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880950233VIOLHFSUSCPUR registered 6 Jul 2026 Active
  • FDA 510(k) K180872 decided 11 Oct 2018 Active
  • FDA GUDID UDI-DI 08809502330422 listed 11 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180872
  2. Listed FDA GUDID 08809502330422
  3. Registered EUDAMED 880950233VIOLHFSUSCPUR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Electrosurgical system
Model / reference
SCARLET PRO
Primary DI / UDI-DI
08809502330422
Basic UDI-DI
880950233VIOLHFSUSCPUR
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrosurgical system

Cleared under the same submission (K180872)

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from VIOL Co., Ltd.

  • Scarlet Pro (Scarlet Pro)

    Class II

  • Cellinew

    Class II

  • Foot Switch F/S-Hrf-Blue

    Class II

  • Scarlet Srf

    Class II

See all devices from VIOL Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)