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Praxiject

by MedXL Inc 6 variants

Ref 3705CModel 3704

Active European Union

CE MDR

Valid until

3 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0682686NS001UK Basic UDI-DI 10682686004878UDI-DIDate16 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620153629 Active Supplemented

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    24 Jul 2023
    Expires
    3 Jan 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
3704, 3705C
Primary DI / UDI-DI
10682686004878
Basic UDI-DI
0682686NS001UK
Direct Marketing DI
10682686004878
EMDN Code
A02010701 Prefilled syringes with sterile physiological solution
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CA-MF-000011111
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from MedXL Inc

See all devices from MedXL Inc →

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