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Black Surgical Mask Type IIR

by New Style Bulgaria EUDAMED

Ref 1 EMDN T020604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number38009101073158 Basic UDI-DIDate1 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Black Surgical Mask Type IIR
Model / Reference
1
Primary DI / UDI-DI
03800910107311
Basic UDI-DI
38009101073158
Direct Marketing DI
03800910107311
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
BG-MF-000022200

Other devices from New Style

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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 f0c01a05-5ba4-4679-8c31-c7ab628179f6 61 fields · synced 22 Oct 2026