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Termoplastik Baş Maskesi

by Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref RTM000100

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-86989403909342 Basic UDI-DI 86989403909342UDI-DIDate13 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
U-Frame Head Mask
Model / Reference
RTM000100
Primary DI / UDI-DI
86989403909342
Basic UDI-DI
B-86989403909342
EMDN Code
Z12011285 Patient positioning instruments - consumables
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000018717

Other devices from Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Reusable

Other properties (10)

  • Sterile: No
  • Implantable: 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