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Dental Wedges

by Faithful Medical (Hebei) Co., ltd

Ref FMPW01-XXXLModel FMPW01 (Specifications: XXXL,XXL, XL,L,M,S,XS), FMPW02 (Specifications:L, M,S,XS), FMPW03 (Specifications:L, M,S), FMPW04 (Specifications:L, M,S), FMPW05 (Specifications:L, M,S,XS), FMPW06 (Specifications:M), FMPW07 (Specifications:L, M,S,XS), etc.

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698025124FMPWJB Basic UDI-DI 06980251240544UDI-DIDate13 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Dental Wedges
Model / Reference
FMPW01 (Specifications: XXXL, XXL, XL, L, M, S, XS), FMPW02 (Specifications:L, FMPW03 (Specifications:L, S), FMPW04 (Specifications:L, FMPW05 (Specifications:L, FMPW06 (Specifications:M), FMPW07 (Specifications:L, etc., FMPW01-XXXL
Primary DI / UDI-DI
06980251240544
Basic UDI-DI
698025124FMPWJB
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000056876
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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