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Aligner Chews

by Dongguan Hengrui Silicone Products Co., Ltd.

Ref HR-001Model HR-001 HR-002 HR-003 HR-004 HR-005 HR-006 HR-007 HR-008 HR-009 HR-010

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697387848HRAC01WQ Basic UDI-DI 06973878480004UDI-DIDate11 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Aligner Chews
Model / Reference
HR-001 HR-002 HR-003 HR-004 HR-005 HR-006 HR-007 HR-008 HR-009 HR-010, HR-001
Primary DI / UDI-DI
06973878480004
Basic UDI-DI
697387848HRAC01WQ
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038651
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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