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Oral tip syringe Low dose (ENFit Compatible)

by Medicina Limited

Ref OT01LD, OT25LD

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-05056115402845 Basic UDI-DI Date12 Jan 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  • Withdrawn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
1ml Low Dose Oral Syringe (ENFit Compatible)
2.5ml Low Dose Oral Syringe (ENFit Compatible)
Model / Reference
OT01LD, OT25LD
Primary DI / UDI-DI
05056115402845, 05056115402852
Basic UDI-DI
B-05056115402845, B-05056115402852
EMDN Code
A020199 Syringes, single-use - other
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
UK-MF-000041402
Authorised representative
HMC PREMEDICAL S.P.A. IT-AR-000029439

Other devices from Medicina Limited

See all devices from Medicina Limited →

Properties

  • Sterile
  • Administering Medicine
  • Measuring Function

Other properties (8)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No