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Therapy™

by Abbott Medical 29 variants

Ref IBI-83701

Therapy™ (IBI-83701) is a Class III device made by Abbott Medical, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 5414734ABS0015BW), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

11 Dec 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414734ABS0015BW Basic UDI-DI 05414734308212UDI-DIDate28 Aug 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781517 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    14 Jan 2026
    Expires
    11 Dec 2028
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Therapy Ablation Catheter
Model / reference
IBI-83701
Primary DI / UDI-DI
05414734308212
Basic UDI-DI
5414734ABS0015BW
EMDN code
C020301 Arrhythmogenic foci radiofrequency ablation catheters
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000014304
Authorised representative
Abbott Medical BE-AR-000008744

Similar devices in this category

Other devices filed under ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS.

Other devices from Abbott Medical

See all devices from Abbott Medical →

Properties

  • Supplied sterile
Other properties (13, all answered No)