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UC50 230V Ultrasonic Cleaner with CE Line Cord

by Coltene/Whaledent Inc.

Ref UC50DB230CE

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D661043KK Basic UDI-DI D661UC50DB230CE0UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD661UC50DB230CE0 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
UC50 230V Ultrasonic Cleaner with CE Line Cord EUDAMED
BioSonic GUDID
Generic Name
Ultrasonic-cleaning water bath
Device Name
BioSonic Ultrasonic Cleaners
Model / Reference
UC50DB230CE
Primary DI / UDI-DI
D661UC50DB230CE0 EUDAMED
D661UC50DB230CE1 GUDID
Basic UDI-DI
++D661043KK
FDA Product Code
FLG
EMDN Code
Z12011302 Ultrasonic cleaning equipment
GMDN Term
Ultrasonic-cleaning water bath
Device Class
Class I
Regulation Number
880.6150
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D661UC50DB230CE0
GUDID
D661UC50DB230CE1

Manufacturer details

EUDAMED SRN
US-MF-000015761
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No