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Medical plastic trays

by Huanghua Promisee Dental Co.Ltd. 12 variants

Ref /Model APT01,AK01, AK01 16, AK01 16a, AK01 17, AK01 18, AK01 19, AK01 20,DPT01,DPT02,DPT03,DPT04,NC01

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 22 Oct 2026. What this means

Overview

Medical plastic trays are versatile, portable medical devices designed for precise patient care. These trays provide a sterile and sanitary environment for various medical procedures, ensuring the accuracy and reliability of results. With their user-friendly design, medical professionals can efficiently manage multiple patients while maintaining high standards of infection control.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69544540MEPT001UF Basic UDI-DI 06954454001479UDI-DIDate17 Mar 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
APT01, AK01, AK01 16, AK01 16a, AK01 17, AK01 18, AK01 19, AK01 20, DPT01, DPT02, DPT03, DPT04, NC01, /
Primary DI / UDI-DI
06954454001479
Basic UDI-DI
69544540MEPT001UF
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

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

Other devices from Huanghua Promisee Dental Co.Ltd.

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Properties

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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