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Silicone Mask, Size 00

by Besmed Health Business Corp. Taiwan EUDAMED

Ref SM-86573 EMDN R020199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SM-8657392 Basic UDI-DIDate1 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Silicone Mask, Size 00
Model / Reference
SM-86573
Primary DI / UDI-DI
D-SM-8657392
Basic UDI-DI
B-SM-8657392
EMDN Code
R020199 Breathing circuits and kits - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 5822cfcc-472e-4516-a656-bbac0df23e2c 61 fields · synced 24 Oct 2026