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06954454016718

by Huanghua Promisee Dental Co.Ltd. China EUDAMED

Ref CR13XLModel CR01L,CR01S,CR02L,CR02M,CR02S,CR03,CR03L,CR03M,CR03S,CR04,CR04L,CR04S,CR05,CR05L,CR05S,CR06,CR07,CR09,CR09L,CR09M,CR09S,CR11L,CR11M,CR11S,CR12L,CR12M,CR12S,CR10,CR10M,CR10S,CR08,CR08L,CR08S,CR0802L,CR0802S,MP01,MP01L,MP01M,MP01S,MP02,MP02L,MP02M,MP02S

EMDN Q010204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69544540DERE001M3 Basic UDI-DIDate6 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Dental Retractor
Model / Reference
CR01L, CR01S, CR02L, CR02M, CR02S, CR03, CR03L, CR03M, CR03S, CR04, CR04L, CR04S, CR05, CR05L, CR05S, CR06, CR07, CR09, CR09L, CR09M, CR09S, CR11L, CR11M, CR11S, CR12L, CR12M, CR12S, CR10, CR10M, CR10S, CR08, CR08L, CR08S, CR0802L, CR0802S, MP01, MP01L, MP01M, MP01S, MP02, MP02L, MP02M, MP02S, CR13XL
Primary DI / UDI-DI
06954454016718
Basic UDI-DI
69544540DERE001M3
EMDN Code
Q010204 Retraction wires and gingival retractors
Device Class
Class I
Market of Registration
Austria

Manufacturer details

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

Other devices from Huanghua Promisee Dental Co.Ltd.

See all devices from Huanghua Promisee Dental Co.Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06954454016718|69544540DERE001M3 61 fields · synced 25 Oct 2026