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PERLE Gel Filled Mammary Implant

by Nagor Limited 15 variants

Ref SOR-LR 105Model SOR

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number006064011B1001AV Basic UDI-DI 00606401000764UDI-DIDate29 Jul 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 773740 Cancelled

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    13 May 2025
    Expires
    12 May 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
SOR, SOR-LR 105
Primary DI / UDI-DI
00606401000764
Basic UDI-DI
006064011B1001AV
Direct Marketing DI
00606401000764
EMDN Code
P0601010201 Breast implants, round, made of silicone, with smooth surface
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
GB-MF-000019179
Authorised representative
GC Aesthetics (Management) Limited IE-AR-000004118

Other devices from Nagor Limited

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Properties

  • 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