Identity
- Trade Name
- Optune Gio EUDAMED
- Device Name
- Optune Gio EUDAMED
- Model / Reference
- TFH9100 EUDAMEDTFH9100EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107986328 EUDAMED
- Basic UDI-DI
- 0729010798373WS 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
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
Category: Dermatological laser beam guiding handpiece
Optune Gio by Novocure GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological laser beam guiding handpiece.
- GentleYAG 1.5/3MM Delivery System W/DCD — Candela Corporation · Class II
- Clear & Brilliant — Solta Medical, Inc. · Class II
- hydrosun 750 — Hydrosun Medizintechnik GmbH · Class IIa
- GentleYAG 3MM Delivery System W/O DCD — Candela Corporation · Class II
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation · Class II
- TL 30 — Globalcare Medical Technology Co., Ltd. · Class IIa
- Open — Candela Corporation · Class II
- HydraFacial — Hydrafacial LLC · Class I
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 | 0729010798373WS | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novocure GmbH
- EUDAMED SRN
- CH-MF-000029002
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED fdb38225-cb63-400c-82d2-ba7264f4e1a1 61 fields · synced May 22, 2026