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Octacare Surgical Mask with Soft Elastic Ears 50 Pcs

by Octamed Sağlik Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref 33001

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86801969EKCM01RH Basic UDI-DI 08680196903693UDI-DIDate23 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Octacare Surgical Mask with Soft Elastic Ears
Model / Reference
33001
Primary DI / UDI-DI
08680196903693
Basic UDI-DI
86801969EKCM01RH
Direct Marketing DI
08680196903693
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
TR-MF-000024356

Other devices from Octamed Sağlik Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Octamed Sağlik Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

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