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Prophy Cup

by Huanghua Promisee Dental Co.Ltd. 8 variants

Ref PC01CModel PC01A,PC01B, PC02A, PC02B, PC03A, PC03B, PC04A, PC04B

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06954454015681 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69544540PRCU001X3 Basic UDI-DI 06954454015681UDI-DIDate20 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Prophy Cup EUDAMED
Cotisen GUDID
Generic Name
Dental polishing cup, single-use
Model / Reference
PC01A, PC01B, PC02A, PC02B, PC03A, PC03B, PC04A, PC04B, PC01C
Primary DI / UDI-DI
06954454015681
Basic UDI-DI
69544540PRCU001X3
FDA Product Code
EHK
EMDN Code
Q010502 Dental polishing cups, single-use
GMDN Term
Dental polishing cup, single-use
Device Class
Class I
Regulation Number
872.6290
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000014766
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Huanghua Promisee Dental Co.Ltd.

See all devices from Huanghua Promisee Dental Co.Ltd. →

Properties

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

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No