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Assupro

by Assut Europe SpA Italy EUDAMED

Ref PU915KBC

EMDN H010201010401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033439ASSUPRO4P Basic UDI-DIDate6 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CVD0048250326 Supplemented

    Technical documentation EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    28 Jan 2026
    Expires
    7 Aug 2028
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PU915KBC
Primary DI / UDI-DI
38033439437102
Basic UDI-DI
8033439ASSUPRO4P
Direct Marketing DI
38033439437102
EMDN Code
H010201010401 Polypropylene monofilament with needle for open surgery
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018178

Other devices from Assut Europe SpA

See all devices from Assut Europe SpA →

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 38033439437102|8033439ASSUPRO4P 61 fields · synced 24 Oct 2026