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Julaïne

by Nordberg Medical AB

Ref DF002, DF001

Active European Union

CE MDR CE MDD

Valid until

27 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 801908 Date28 Jul 2026IssuedStatusActive expires 27 Jul 2031
European UnionCE/MDD NumberB-DF002QN Basic UDI-DI Date22 Oct 2024RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 801908 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    28 Jul 2026
    Expires
    27 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
Julaïne
Juläine
Model / Reference
DF002, DF001
Primary DI / UDI-DI
D-DF002QN, D-DF001QL, 07350162940120, 07350162940137, 07350162940113
Basic UDI-DI
B-DF002QN, B-DF001QL, 735016294JulaineQW
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000035493

Other devices from Nordberg Medical AB

  • Juläine

    Class III

  • Juläine

    Class III

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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