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Optune HFE Transducer Array, black
EUDAMEDClass IIb (EU MDR)
Ref IHEP9020BEUModel IHEP9020B, IHEP9020W
Identity
- Trade Name
- Optune HFE Transducer Array, black EUDAMED
- Device Name
- Optune HFE Transducer Arrays EUDAMED
- Model / Reference
- IHEP9020B, IHEP9020W EUDAMEDIHEP9020BEU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107987387 EUDAMED
- Basic UDI-DI
- 0729010798394X2 EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optune HFE Transducer Array, black by Novocure GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0729010798394X2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novocure GmbH
- EUDAMED SRN
- CH-MF-000029002
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d11a1e5b-4529-44d8-93c9-9eddf5254316 61 fields · synced Oct 6, 2026