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Ovem

by Yilmaz Bi̇o Medi̇kal San. Ve Ti̇c.ltd.şti̇ 148 variants

Ref OME 101-RModel OME 101-R STERİL EPİDERMAL PRİCK TESTİ APLİKATÖRÜ 8 PİNLİ

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699495391919 Basic UDI-DI 08699495391919UDI-DIDate12 Oct 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  • Withdrawn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

Model / Reference
OME 101-R STERİL EPİDERMAL PRİCK TESTİ APLİKATÖRÜ 8 PİNLİ, OME 101-R
Primary DI / UDI-DI
08699495391919
Basic UDI-DI
B-08699495391919
EMDN Code
W01020299 Allergy tests - other
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016027

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Properties

  • Sterile

Other properties (12)

  • 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