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Orthodontic Face Mask

by Creative Dental 6 variants

Part of a family of 6 devices: see the family page

Ref Large comicModel Large/Small

Orthodontic Face Mask (Large comic) is a Class I device made by Creative Dental, registered in EUDAMED on 3 Jul 2025 (Basic UDI-DI 697443505FaceMaskBZ), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697443505FaceMaskBZ Basic UDI-DI 06942665514284UDI-DIDate3 Jul 2025RegisteredStatusActive

Official records

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  • Withdrawn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
Large/Small, Large comic
Primary DI / UDI-DI
06942665514284
Basic UDI-DI
697443505FaceMaskBZ
EMDN code
Q010499 Orthodontic devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000025975
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Other devices filed under ORTHODONTIC DEVICES - OTHER.

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Properties

Other properties (14, all answered No)