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Biofibre 4.0 e Medicap High Density 4.0

by Medicap S.r.l Italy EUDAMED

Ref BF24.10L.45 EMDN P9099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0002220326 Date30 Sep 2026IssuedStatusActive expires 22 Dec 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0002220326 Supplemented

    Quality management system EU MDR

    Issued
    30 Sep 2026
    Expires
    22 Dec 2027
    Reason
    Change approved
  • CVD0001220126 Supplemented

    Technical documentation EU MDR

    Issued
    30 Sep 2026
    Expires
    22 Dec 2027
    Reason
    Change approved

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Biofibre 4.0 e Medicap High Density 4.0
Model / Reference
BF24.10L.45
Primary DI / UDI-DI
08057158964496
Basic UDI-DI
805715896TF05HF
EMDN Code
P9099 Implantable prosthetic devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007995

From the manufacturer

Manufacturer's product page: Perché Medicap® 4.0 Hair Implant System

Other devices from Medicap S.r.l

See all devices from Medicap S.r.l →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (12)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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 e7fb8a73-b9cd-48fe-929b-080642902750 61 fields · synced 25 Oct 2026