Skip to content

Medical Packaging materials

by TOPDENT Co., Ltd. China EUDAMED

Ref 162374

EMDN S01010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69744860700030001RD Basic UDI-DIDate23 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Medical Packaging materials
Model / Reference
162374
Primary DI / UDI-DI
06974486070533
Basic UDI-DI
69744860700030001RD
EMDN Code
S01010101 Sterilisation pouches, flat, paper/plastic film
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000012237
Authorised representative
TopDent GmbH DE-AR-000005681

Other devices from TOPDENT Co., Ltd.

See all devices from TOPDENT 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 1d79bf5e-8a17-417b-90b1-cb824e1e238a 61 fields · synced 23 Oct 2026