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Rozplňovací stanice automatická dvojitá PT459R5

by Lynax s.r.o.

Model Dispensing Unit

Active European Union

CE MDR

Valid until

15 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

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 Number2026-MDR/QA-037/A Date17 Jul 2026IssuedStatusActive expires 15 Jun 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QA-037/A Active Amended

    Quality assurance EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    17 Jul 2026
    Expires
    15 Jun 2031
    Reason
    Mnf data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dispensing unit
Model / Reference
Dispensing Unit
Primary DI / UDI-DI
08594216370023
Basic UDI-DI
859421637ROZUQ
Direct Marketing DI
08594216370023
EMDN Code
Z11029005 Automatic dose calibrators
Device Class
Class I
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
CZ-MF-000034349

Other devices from LYNAX s.r.o.

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

  • 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
  • Incorporates Medicinal Product: No