Skip to content

Biofibre 4.0 e Medicap High Density 4.0

by Medicap S.r.l EUDAMED

Active European Union

Ref BFX4.21RDL.45

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  • Withdrawn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

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    30 Sep 2026
    Expires
    22 Dec 2027
    Reason
    Change approved
  • CVD0001220126 Supplemented

    Technical documentation EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    30 Sep 2026
    Expires
    22 Dec 2027
    Reason
    Change approved

Specification

EUDAMED

Device Name
Biofibre 4.0 e Medicap High Density 4.0
Model / Reference
BFX4.21RDL.45
Primary DI / UDI-DI
08057158964878
Basic UDI-DI
805715896TF05HF
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 →