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Nagor Limited

by Nagor Limited EUDAMED

Active European Union

Ref TE-XM3 200Model TE-XF3 150

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00606401172072 Basic UDI-DIDate6 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 773742 Cancelled

    Technical documentation EU MDR

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

Specification

EUDAMED

Trade Name
Nagor Limited
Blossom™ IVTE
Device Name
Integrated Valve Tissue Expander. Anatomical Textured – Moderate Height, High Projection
Integrated Valve Tissue Expander
Model / Reference
TE-XM3 200, TE-XF3 150
Primary DI / UDI-DI
00606401172072
Basic UDI-DI
B-00606401172072, 006064011C2005BP
Direct Marketing DI
00606401172072
EMDN Code
P900103 Breast tissue expanders
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