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UltraPrint Denture Teeth UV

by Guangzhou Heygears Imc.inc 5 variants

Ref MA.003.993Model Denture Teeth UV A1;Denture Teeth UV A2;Denture Teeth UV A3;Denture Teeth UV B1;Denture Teeth UV BL

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 Number697143794DentureTeethYZ Basic UDI-DI 06971437944783UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971437944783 UDI-DI Date14 Jan 2026ListedStatusListed GUDID: not 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  • Withdrawn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

Generic Name
Resin artificial teeth
Model / Reference
Denture Teeth UV A1 EUDAMED
Denture Teeth UV A2 EUDAMED
Denture Teeth UV A3 EUDAMED
Denture Teeth UV B1 EUDAMED
Denture Teeth UV BL EUDAMED
MA.003.993 EUDAMED
2.0 GUDID
Primary DI / UDI-DI
06971437944783
Basic UDI-DI
697143794DentureTeethYZ
FDA Product Code
PZY
EMDN Code
Q0102050101 Temporary teeth resins
GMDN Term
Resin artificial teeth
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3590
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000010624
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangzhou Heygears Imc.inc

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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