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Virtue Rf

by SHENB Co., Ltd.

Ref SH-017Model VIRTUE RF

Virtue Rf (SH-017) is a radio-frequency skin surface treatment system (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by shenb Co., Ltd., registered in EUDAMED on 12 Oct 2022 (Basic UDI-DI 88000171SH017CK), cleared under FDA 510(k) K211562 on 23 Nov 2021 (1 earlier submission) and listed in FDA GUDID since 8 Dec 2021 (UDI-DI 08800017100821), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211562↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000171SH017CK Basic UDI-DI 08800017100821UDI-DIDate12 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08800017100821 UDI-DI Date8 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK211562 Date23 Nov 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000171SH017CK registered 12 Oct 2022 Active
  • FDA 510(k) K211562 decided 23 Nov 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800017100821 listed 8 Dec 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K202415
  2. Cleared FDA 510(k) K211562
  3. Listed FDA GUDID 08800017100821
  4. Registered EUDAMED 88000171SH017CK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Radio-frequency skin surface treatment system
Model / reference
VIRTUE RF EUDAMED
SH-017 EUDAMED
VirtueRF GUDID
Primary DI / UDI-DI
08800017100821
Basic UDI-DI
88000171SH017CK
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Radio-frequency skin surface treatment system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
VIRTUE RF
SH-017
GUDID
VirtueRF
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.

Manufacturer details

EUDAMED SRN
KR-MF-000021619
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Foot-switch, electrical

Similar devices in this category

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

Other devices from shenb Co., Ltd.

See all devices from shenb Co., Ltd. →

Properties

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