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Disposable Bite Trays

by Wellmed Dental Medical Supply Co., Ltd 53 variants

Ref PFT-011/2002Model 011/2002, Perfection Plus Impression Tray

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697460865011/2002QP Basic UDI-DI Date14 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Perfection Plus 1-2-3 Trays
Device Name
Disposable Bite Trays
Perfection Plus 1-2-3 Tray
Model / Reference
011/2002, PFT-011/2002, Perfection Plus Impression Tray
Primary DI / UDI-DI
05060660617388, 15060660617385
Basic UDI-DI
697460865011/2002QP, 506066061TFPP/012KJ
EMDN Code
Q010503 Impression material trays, single-use
Device Class
Class I
EU market of registration
Austria
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000003243
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wellmed Dental Medical Supply Co., Ltd

See all devices from Wellmed Dental Medical Supply Co., Ltd →

Properties

Other properties (13)

  • 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