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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Optune HFE Transducer Arrays — 4 UDI-DI variants, MDR (Novocure GmbH)

MD Atlas
Novocure GmbH

Data from EUDAMED, last updated May 23, 2026

Optune HFE Transducer Arrays

0729010798394X2

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: Novocure GmbH

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Device characteristics

Active device

Legacy certificates

Certificate number: HZ 1990188-1
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: TÜV Rheinland LGA Products GmbH (0197)
Validity: Nov 10, 2025 → Mar 23, 2027

Identity & classification

Basic UDI-DI: 0729010798394X2
Device name: Optune HFE Transducer Arrays
Device model: IHEP9020B, IHEP9020W
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Mar 17, 2026

Manufacturer & authorised representative

Manufacturer

Name: Novocure GmbH
SRN: CH-MF-000029002
Country: Switzerland
Email: info@novocure.com

Authorised representative

Name: MDSS GmbH
SRN: DE-AR-000005430
Country: Germany

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01GJ0XETD90DRXKCX30N5JA112

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

flex transducer array, black07290107984485
flex transducer array, white07290107984492
IHEP9020BEU07290107987387
IHEP9020WEU07290107987394