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Trace-28 disclosing tablets bulk pack

by Young Dental Manufacturing I, LLC

Ref 232200Model Plaque Dislcosing Products

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 Number03027360408D530780QJCSZ Basic UDI-DI 10302732322007UDI-DIDate21 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10302732322007 UDI-DI Date17 Feb 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  • Withdrawn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
Trace-28 disclosing tablets bulk pack EUDAMED
Young Dental GUDID
Generic Name
Dental caries detecting stain
Model / Ref / Catalog
Plaque Dislcosing Products, 232200
Primary DI / UDI-DI
10302732322007 EUDAMED
00302732322000 GUDID
Basic UDI-DI
03027360408D530780QJCSZ
FDA Product Code
QJC
EMDN Code
Q019003 Dental floss and other devices for oral hygiene (for professional use)
GMDN Term
Dental caries detecting stain
Device Class
Class I
Regulation Number
872.6855
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10302732322007
GUDID
00302732322000

Manufacturer details

EUDAMED SRN
US-MF-000027132
Authorised representative
Young Microbrush Ireland Ltd IE-AR-000011249

Other devices from Young Dental Manufacturing I, LLC

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No