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Dental Wedge

by Huanghua Promisee Dental Co.Ltd. 28 variants

Ref PWO5LModel PW01,PW01L,PW01M,PW01S,PW01SS,PW02,PW02L,PW02M,PW02S,PW02SS,PW03,PW04,PW04L,PW04M,PW04S,PW05,PW05L,PW05M,PW05S,PW06,PW06L,PW06S,PW07,PW07L,PW07M,PW07S,WG01,WG01L,WG01M,WG01S,SC0301,RD09

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69544540DEWE001NS Basic UDI-DI 06954454001561UDI-DIDate14 Mar 2025RegisteredStatusActive

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  • Withdrawn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
PW01, PW01L, PW01M, PW01S, PW01SS, PW02, PW02L, PW02M, PW02S, PW02SS, PW03, PW04, PW04L, PW04M, PW04S, PW05, PW05L, PW05M, PW05S, PW06, PW06L, PW06S, PW07, PW07L, PW07M, PW07S, WG01, WG01L, WG01M, WG01S, SC0301, RD09, PWO5L
Primary DI / UDI-DI
06954454001561
Basic UDI-DI
69544540DEWE001NS
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000014766
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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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