Skip to content

Well-Prep WE118-K000

by Vericom Co., Ltd.

Ref WE118-K000

Well-Prep WE118-K000 is a device classified as Class IIa in the EU and Class I in the US made by Vericom Co., Ltd., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-08809254452205) and listed in FDA GUDID since 1 Nov 2016 (UDI-DI 08809254452205), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809254452205 Basic UDI-DI 08809254452205UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809254452205 UDI-DI Date1 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809254452205 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 08809254452205 listed 1 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809254452205
  2. Registered EUDAMED B-08809254452205

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Well-Prep
Generic name
Dental tooth-cleaning solution
Device name
Root canal cleanser
Model / reference
WE118-K000
Primary DI / UDI-DI
08809254452205
Basic UDI-DI
B-08809254452205
FDA product code
EKQ
EMDN code
Q01010299 Root canal filling devices - other
GMDN term
Dental tooth-cleaning solution
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Dental tooth-cleaning solution

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DEVICES - OTHER.

Other devices from Vericom Co., Ltd.

See all devices from Vericom Co., Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)