Identity
- Trade Name
- NovoTAL flex EUDAMEDFDA UDI
- Generic Name
- Alternating electric field antimitotic cancer treatment system FDA UDI
- Device Name
- NovoTAL flex EUDAMED
- Model / Reference
- 1.0 EUDAMEDSW000128 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SW000128 FDA UDI
- Primary DI / UDI-DI
- 07290107984447 EUDAMEDFDA UDI
- Basic UDI-DI
- 0729010798304W7 EUDAMED
- Direct Marketing DI
- 07290107984447 EUDAMED
- PMA Number
- P100034 FDA UDI
- FDA Product Code
- NZK FDA UDI
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Alternating electric field antimitotic cancer treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NovoTAL flex by Novocure GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0729010798304W7 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Novocure GmbH
- EUDAMED SRN
- CH-MF-000029002
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 48434d0f-3a47-47c8-85a9-fb48a9659366 61 fields · synced Jun 18, 2026
- FDA UDI dd92e4ca-75bb-4876-becb-0e922962c394 34 fields · synced May 30, 2026