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Nagor Limited

by Nagor Limited EUDAMED

Withdrawn No longer placed on the EU market

Ref SOR-HR 210Model SOR

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00606401180220 Basic UDI-DIDate6 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  • Withdrawn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European Union — CE/MDD Withdrawn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- high range
PERLE Gel Filled Mammary Implant
Model / Reference
SOR-HR 210, SOR
Primary DI / UDI-DI
00606401180220
Basic UDI-DI
B-00606401180220, 006064011B1001AV
Direct Marketing DI
00606401180220
EMDN Code
P0601010201 Breast implants, round, made of silicone, with smooth surface
Device Class
Class III
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

See all devices from Nagor Limited →

Properties

Show 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