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Wax Rim

by Huanghua Promisee Dental Co.Ltd. China EUDAMED

Ref BP04BModel IT01,IT0101,IT0102,IT0103,IT0104,IT0105,IT0106,IT0107,IT0108,IT0109,IT0110,IT02,IT0201,IT0202,IT0203,IT0204,IT0205,IT0206,IT0207,IT0208,IT0209,IT0210,IT05,IT07,BT,BT01,BT02,BT03,BT04,BT05,IT08,IT06,TB01,TB01L,TB01M,TB01S,BP01,BP02,BP03,BP04, BP04B

EMDN Q010503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69544540IMTR001WH Basic UDI-DIDate11 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
Impression Tray
Model / Reference
IT01, IT0101, IT0102, IT0103, IT0104, IT0105, IT0106, IT0107, IT0108, IT0109, IT0110, IT02, IT0201, IT0202, IT0203, IT0204, IT0205, IT0206, IT0207, IT0208, IT0209, IT0210, IT05, IT07, BT, BT01, BT02, BT03, BT04, BT05, IT08, IT06, TB01, TB01L, TB01M, TB01S, BP01, BP02, BP03, BP04, BP04B
Primary DI / UDI-DI
06954454005712
Basic UDI-DI
69544540IMTR001WH
EMDN Code
Q010503 Impression material trays, single-use
Device Class
Class I
Market of Registration
Spain

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 06954454005712|69544540IMTR001WH 61 fields · synced 25 Oct 2026