Identity
- Trade Name
- Optune Lua EUDAMED
- Device Name
- Optune Lua EUDAMED
- Model / Reference
- TFT9200 EUDAMEDTFT9200EU EUDAMEDTFT9201EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107983112 EUDAMED07290107983075 EUDAMED
- Basic UDI-DI
- 0729010798374WU EUDAMED0729010798403WA EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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 Lua 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 | 0729010798374WU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novocure GmbH
- EUDAMED SRN
- CH-MF-000029002
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 1287d08d-8b93-4203-adf4-f065ab41fd81 61 fields · synced Jul 21, 2026
- EUDAMED 3631ea0a-af6d-46a0-bc10-043f05afdabf 61 fields · synced May 19, 2026