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Nagor Limited

by Nagor Limited EUDAMED

Withdrawn No longer placed on the EU market

Ref SOR- EHR 520, SOR-EHR 520Model SOR

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00606401180510 Basic UDI-DIDate7 Oct 2022RegisteredStatusWithdrawn No longer placed on the EU market
European UnionCE/MDD NumberB-00606401180510 Basic UDI-DIDate7 Oct 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 773740 Cancelled

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    13 May 2025
    Expires
    12 May 2030
    Reason
    Other

Specification

EUDAMED

Trade Name
Nagor Limited
Perle™
Device Name
PERLE TM gel-filled mammary implants: soft, high cohesive gel-filled smooth- extra high range
PERLE Gel Filled Mammary Implant
Model / Reference
SOR- EHR 520, SOR, SOR-EHR 520
Primary DI / UDI-DI
00606401180510
Direct Marketing DI
00606401180510
Market of Registration
Northern Ireland
Austria

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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