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Elite Extend Flex Latex Free Pink Prophy Cup 144 Count

by Young Dental Manufacturing I, LLC

Ref 057901Model Prophy Angle Attachment

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

CE MDR CE MDD

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 NumberB-10302730579014 Basic UDI-DI 10302730579014UDI-DIDate21 Nov 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-10302730579014 Basic UDI-DI 10302730579014UDI-DIDate21 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10302730579014 UDI-DI Date16 Oct 2022ListedStatusListed 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Elite Extend Flex Latex Free Pink Prophy Cup 144 Count EUDAMED
Young GUDID
Generic Name
Dental polishing cup, single-use
Model / Ref / Catalog
057901, Prophy Angle Attachment
Primary DI / UDI-DI
10302730579014 EUDAMED
00302730579017 GUDID
Basic UDI-DI
B-10302730579014, 03027316184Q017332EHK3L
FDA Product Code
EHK
EMDN Code
Q01010403 Dental abrasive and polishing materials
GMDN Term
Dental polishing cup, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.6290
EU market of registration
Netherlands
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10302730579014
GUDID
00302730579017
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

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

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Properties

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

Other properties (18)

  • Sterile: 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