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VenusP-Valve System

by Venus Medtech (Hangzhou) Inc. MF 10 variants

Ref P32-30Model L28P，L30P，L32P，L34P，L36P

Expiring European Union

CE MDR

Valid until

1 Apr 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2245375CE01 Date19 Aug 2026IssuedStatusExpiring expires 1 Apr 2027

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2245375CE01 Expiring Amended Expires in 151 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    19 Aug 2026
    Expires
    1 Apr 2027
    Reason
    Other
  • 2245375TD01 Expiring Supplemented Expires in 151 days

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 Nov 2025
    Expires
    1 Apr 2027
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
VenusP-Valve System, Percutaneous Pulmonary Valve
Model / Reference
L28P，L30P，L32P，L34P，L36P, P32-30
Primary DI / UDI-DI
06970872490299
Basic UDI-DI
6970872490001BQ
EMDN Code
P070301030103 Stented biological pulmonary valves for percutaneous implant - valve tissue of animal origin
Device Class
Class III
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000021841
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No