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Clear Aligner System

by Shanghai EA Medical Instruments Co., Ltd.

Ref Clear Aligner SystemModel Pro, Select, Kid, Retainer, TA, TB

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697720704CAS001B8 Basic UDI-DI Date6 May 2026RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Clear Aligner
Clear Retainer
Orthodontic Attachment Template
Model / Reference
Clear Aligner System, Pro, Select, Kid, Retainer, TA, TB
Primary DI / UDI-DI
06977207040457, 06977207040501, 06977207040419, 06977207040525, 06977207040464, 06977207040396, 06977207040402, 06977207040518, 06977207040426, 06977207040488, 06977207040495, 06977207040471, 06977207040440, 06977207040433
Basic UDI-DI
697720704CAS001B8, 697720704Aligner001HT, 697720704CAS002BA, 697720704Retainer001JT, 697720704AT001BX
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
Class I
EU market of registration
France
Medical Purpose
indicated for the alignment of teeth during orthodontic treatment of malocclusion
In the state of use, device covers the crown part of the patient's teeth. By taking advantage of the difference between the corresponding tooth positions on Device and the actual positions of the corresponding teeth on the patient's actual jaw, Device elastically deforms to generate a rebound force, thereby causing the teeth to move and achieving the correction of dental malocclusion.

Manufacturer details

EUDAMED SRN
CN-PR-000053735

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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