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Nagor Limited

by Nagor Limited EUDAMED

Active European Union

Ref IMP-HR 180, TE-XM3 500, IMP-EHR 270, TE-XF3 400, GS-XM2 290, SOR-MR 300, IMP-MR 150, GS-HR 210, IMP-MR 330, GS-EHR 210, IMP-HR 330, IMP-SHR 460, SOR- EHR 230, XM1- 275, GS-XM3 300, SOR- EHR 160, IMP-SEHR 460, TE-XF3 500, GS-EHR 330, GS-XM2 215, IMP-HR 420, SOR-HR 235, SOR-HR 360, IMP-HR 240, GS-EHR 360, IMP-SMR 270, IMP-SEHR 360, SOR- EHR 360, GS-HR 360, XF1- 235, SOR-MR 190, GS-XM3 190, SOR-HR 300, GS-XF2 505, GS-XF2 450, TE-XM3 700, TFI-2, IMP-SEHR 390, GS-XM2 320, GS-EHR 300, IMP-EHR 240, GS-MR 240, IMP-HR 390, SOR-MR 365, GS-MR 460, TGID-1, GS-MR 330, SOR-HR 335, IMP-EHR 360, TE-XL3 500, GS-XF3 235Model XM1-275, GS-XF2 250

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 773740 Date13 May 2025IssuedStatusWithdrawn cancelled expires 12 May 2030 withdrawn 5 Aug 2026
European UnionCE/MDD NumberB-00606401147025 Basic UDI-DIDate11 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 773740 Cancelled

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    13 May 2025
    Expires
    12 May 2030
    Reason
    Other
  • MDR 773742 Cancelled

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    5 Jun 2025
    Expires
    28 Nov 2029
    Reason
    Other

Specification

EUDAMED

Device Name
Textured Impleo gel-filled mammary implants: soft, high cohesive gel-filled textured – high range
Integrated Valve Tissue Expander. Anatomical Textured – Moderate Height, High Projection
Textured Impleo gel-filled mammary implants: soft, high cohesive gel-filled textured – extra high range
INTEGRATED VALVE TISSUE EXPANDERS -Anatomical Textured – Full Height, High Projection
Anatomical Gel Filled Mammary Sizer- Moderate Height, Moderate Projection
PERLE TM gel-filled mammary implants: soft, high cohesive gel-filled smooth- moderate range
Textured Impleo gel-filled mammary implants: soft, high cohesive gel-filled textured – moderate range
Round Gel filled Mammary Sizers- High Profile
Round Gel filled Mammary Sizers- Extra High Profile
Smooth Impleo gel-filled mammary implants: soft, high cohesive gel-filled smooth – high range
PERLE TM gel-filled mammary implants: soft, high cohesive gel-filled smooth- extra high range
9-cell Cogel anatomical gel-filled mammary implants: Soft, form stable cohesive gel-filled textured anatomical – moderate height, low projection (CoGel)
Anatomical Gel Filled Mammary Sizers- Moderate Height, High Projection
Smooth Impleo gel-filled mammary implants: soft, high cohesive gel-filled smooth – extra high range
INTEGRATED VALVE TISSUE EXPANDERS - Anatomical Textured – Full Height, High Projection
PERLE TM gel-filled mammary implants: soft, high cohesive gel-filled smooth- high range
Smooth Impleo gel-filled mammary implants: soft, high cohesive gel-filled smooth – moderate range
9-cell Cogel anatomical gel-filled mammary implants: Soft, form stable cohesive gel-filled textured anatomical - full height, low projection (CoGel)
Anatomical Gel Filled Mammary Sizers- Full Height, Moderate Projection
TFI LSR Filled Testicular Implant
Round Gel filled Mammary Sizers- Moderate Profile
TGI-D Gel Filled Testicular Implant
Integrated Valve Tissue Expander. Anatomical Textured – Low Height, High Projection
Anatomical Gel Filled Mammary Sizers- Full Height, High Projection
Model / Reference
IMP-HR 180, TE-XM3 500, IMP-EHR 270, TE-XF3 400, GS-XM2 290, SOR-MR 300, IMP-MR 150, GS-HR 210, IMP-MR 330, GS-EHR 210, IMP-HR 330, IMP-SHR 460, SOR- EHR 230, XM1-275, XM1- 275, GS-XM3 300, SOR- EHR 160, IMP-SEHR 460, TE-XF3 500, GS-EHR 330, GS-XM2 215, IMP-HR 420, SOR-HR 235, SOR-HR 360, IMP-HR 240, GS-EHR 360, IMP-SMR 270, IMP-SEHR 360, SOR- EHR 360, GS-HR 360, XF1- 235, SOR-MR 190, GS-XM3 190, SOR-HR 300, GS-XF2 505, GS-XF2 250, GS-XF2 450, TE-XM3 700, TFI-2, IMP-SEHR 390, GS-XM2 320, GS-EHR 300, IMP-EHR 240, GS-MR 240, IMP-HR 390, SOR-MR 365, GS-MR 460, TGID-1, GS-MR 330, SOR-HR 335, IMP-EHR 360, TE-XL3 500, GS-XF3 235
Primary DI / UDI-DI
00606401147025, 00606401172102, 00606401148053, 00606401172027, 00606401175516, 00606401180053, 00606401146011, 00606401175080, 00606401146073, 00606401175172, 00606401147070, 00606401152210, 00606401180435, 00606401163070, 00606401175608, 00606401180404, 00606401152340, 00606401172034, 00606401175219, 00606401175493, 00606401147100, 00606401180237, 00606401180275, 00606401147049, 00606401175226, 00606401152043, 00606401152319, 00606401180473, 00606401175134, 00606401160055, 00606401180015, 00606401175578, 00606401180251, 00606401175356, 00606401175349, 00606401172126, 00606401109023, 00606401152326, 00606401175523, 00606401175202, 00606401148046, 00606401175004, 00606401147094, 00606401180077, 00606401175073, 00606401108019, 00606401175035, 00606401180268, 00606401148084, 00606401172164, 00606401175387
Market of Registration
Northern Ireland

Manufacturer details

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

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