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Orthodontic Archwire

by Hefei Mlush Sanitary Products Co., Ltd EUDAMED

Active European Union

Ref MK008Model MKOA1358

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697585675MKOA6245JT Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Orthodontic Archwire
Model / Reference
MKOA1358, MK008
Primary DI / UDI-DI
06975856751427
Basic UDI-DI
697585675MKOA6245JT
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000009828
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Hefei Mlush Sanitary Products Co., Ltd

See all devices from Hefei Mlush Sanitary Products 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