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Sphere-9™

by Medtronic, Inc. United States EUDAMED

Ref AFR-00001

EMDN C020399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0763000B000262284 Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 039709 1510 Supplemented

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    30 Jul 2026
    Expires
    26 Jan 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Sphere 9 Catheter
Model / Reference
AFR-00001
Primary DI / UDI-DI
00199150071258
Basic UDI-DI
0763000B000262284
EMDN Code
C020399 Cardiac tissue ablation devices - other
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000019977
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • 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

Sources (1)

  • EUDAMED 00199150071258|0763000B000262284 61 fields · synced 25 Oct 2026