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Vls-55T

by Sonoscape Medical Corp.

Ref /Model VLS-55Q, VLS-55T

Vls-55T is a device classified as Class IIa in the EU and Class II in the US made by Sonoscape Medical Corp., registered in EUDAMED on 26 Oct 2023 (Basic UDI-DI 69458686VLS-555D), cleared under FDA 510(k) K211882 on 1 Apr 2022 and listed in FDA GUDID since 7 Apr 2022 (UDI-DI 06945868603618), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211882

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69458686VLS-555D Basic UDI-DI 06945868603618UDI-DIDate26 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945868603618 UDI-DI Date7 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211882 Date1 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69458686VLS-555D registered 26 Oct 2023 Active
  • FDA 510(k) K211882 decided 1 Apr 2022 Active
  • FDA GUDID UDI-DI 06945868603618 listed 7 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211882
  2. Listed FDA GUDID 06945868603618
  3. Registered EUDAMED 69458686VLS-555D

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  • Withdrawn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

Trade name
Vls-55T EUDAMED
SonoScape GUDID
Generic name
Endoscopic light source unit, line-powered
Device name
Light Source
Model / reference
VLS-55Q, VLS-55T, /
Primary DI / UDI-DI
06945868603618
Basic UDI-DI
69458686VLS-555D
FDA product code
NWB
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic light source unit, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
VLS-55Q, VLS-55T
/
GUDID
VLS-55T
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
CN-MF-000009623
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Endoscopic light source unit, line-powered

Similar devices in this category

Other devices filed under LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY.

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)