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Novuma

by Burgeon Biyoteknoloji Ve San. Tic.a.s. Türkiye EUDAMED

Ref NOV201901

EMDN P900402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86824768001NV0101G7 Basic UDI-DIDate25 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2025/0003 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2292
    Issued
    21 Feb 2025
    Expires
    20 Feb 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Novuma Collagen Stimulating Calcium Hydroxyapatite Sterile Dermal Filling Material
Model / Reference
NOV201901
Primary DI / UDI-DI
08682476800104
Basic UDI-DI
86824768001NV0101G7
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016410

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED c5e1aaaf-b5e7-4d7f-a9ce-62ea46108371 61 fields · synced 22 Oct 2026