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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Optune HFE Transducer Array, black

UDI-DI 07290107987387Basic UDI-DI 0729010798394X2

Class IIb · MDR · Novocure GmbH

Identification
Model
IHEP9020B, IHEP9020W
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

HZ 1990188-1

EU quality management system · unknown

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-11-10 · Expiry 2027-03-23

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Novocure GmbH

SRN CH-MF-000029002

CH · Baar

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/optune-hfe-transducer-array-black-7387 · UDI page: /udi/07290107987387

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