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BEL-GEN Cold Storage Solution

by Institut Georges Lopez 2 variants

Ref BELGEN/1000Model Static solution for organ preservation

Active European Union

CE MDR

Valid until

13 Mar 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 749160 Date10 Sep 2026IssuedStatusActive expires 13 Mar 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 749160 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    10 Sep 2026
    Expires
    13 Mar 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
IGL-1 Organ Preservation Solution
Model / Reference
Static solution for organ preservation, BELGEN/1000
Primary DI / UDI-DI
13700911900003
Basic UDI-DI
37009119STATIC_SOLUTIONLW
EMDN Code
A090102 Organ preservation solutions
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000009502

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Properties

  • Sterile
  • Incorporates Medicinal Product

Other properties (11)

  • Implantable: No
  • 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