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Biofibre 4.0 e Medicap High Density 4.0

by Medicap S.r.l EUDAMED

Active European Union

Ref BF24.10RD, ME24.02L.30, BF24.11RAL.30, BF24.02RBL.30, BF24.13RC, BF24.12RDL.30, BF24.02RB, BF24.01L.30, BF24.09RCL.30, BF24.04RA, BF24.12RB, BF24.04RDL.45, ME24.03L.30, BF24.17, BF24.06RB, ME24.06L.30, BF24.14RCL.45, BF24.01RD, ME24.14, BF24.11RCL.45, BF24.07RDL.30, BF24.08RDL.45, BF24.02RC, BF24.14RB, ME24.06L.45, BF24.02RDL.30, BF24.06RDL.45, BF24.06RA, BF24.03RB, ME24.09, BFX4.21L.30, BF24.03RCL.45, ME24.13, BF24.05RB, BF24.08RC, BF24.10RCL.30, BF24.13RDL.30, BF24.04RC, BF24.10RC, BF24.09RD, ME24.01L.30, BF24.17RCL.30, BF24.05L.45, BFX4.21RB, BF24.12RA, BF24.07RB, BFX4.21RAL.30, BF24.11, ME24.14L.30, BF24.04L.45, BF24.05RDL.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  • Withdrawn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
BF24.10RD, ME24.02L.30, BF24.11RAL.30, BF24.02RBL.30, BF24.13RC, BF24.12RDL.30, BF24.02RB, BF24.01L.30, BF24.09RCL.30, BF24.04RA, BF24.12RB, BF24.04RDL.45, ME24.03L.30, BF24.17, BF24.06RB, ME24.06L.30, BF24.14RCL.45, BF24.01RD, ME24.14, BF24.11RCL.45, BF24.07RDL.30, BF24.08RDL.45, BF24.02RC, BF24.14RB, ME24.06L.45, BF24.02RDL.30, BF24.06RDL.45, BF24.06RA, BF24.03RB, ME24.09, BFX4.21L.30, BF24.03RCL.45, ME24.13, BF24.05RB, BF24.08RC, BF24.10RCL.30, BF24.13RDL.30, BF24.04RC, BF24.10RC, BF24.09RD, ME24.01L.30, BF24.17RCL.30, BF24.05L.45, BFX4.21RB, BF24.12RA, BF24.07RB, BFX4.21RAL.30, BF24.11, ME24.14L.30, BF24.04L.45, BF24.05RDL.45
Primary DI / UDI-DI
08057158963536, 08057158965059, 08057158963864, 08057158963932, 08057158963406, 08057158964359, 08057158963130, 08057158963604, 08057158964168, 08057158962997, 08057158963239, 08057158964755, 08057158965066, 08057158962942, 08057158963178, 08057158965097, 08057158964694, 08057158963444, 08057158965011, 08057158964663, 08057158964304, 08057158964793, 08057158963291, 08057158963253, 08057158965257, 08057158964250, 08057158964779, 08057158963017, 08057158963147, 08057158964960, 08057158963758, 08057158964588, 08057158965004, 08057158963161, 08057158963352, 08057158964175, 08057158964366, 08057158963314, 08057158963376, 08057158963529, 08057158965042, 08057158964229, 08057158964441, 08057158963277, 08057158963079, 08057158963185, 08057158963918, 08057158962904, 08057158965172, 08057158964434, 08057158964762
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

Show properties
  • 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