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OneTouch Delica Plus Lancets

by Asahi Polyslider Company, Limited

Ref 013-019Model 114301-592

Active European Union

CE MDR

Valid until

20 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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/MDR Number458050578OTDPLANCETMX Basic UDI-DI 04580505780714UDI-DIDate2 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP26/00000018 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    20 Jan 2026
    Expires
    20 Jan 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
OneTouch Delica Plus Lancet
Model / Reference
114301-592, 013-019
Primary DI / UDI-DI
04580505780714
Basic UDI-DI
458050578OTDPLANCETMX
Unit of Use DI
84580505780710
EMDN Code
V010402 Lancets without safety systems, single-use
Device Class
Class IIa
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
JP-MF-000009245
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No