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ILE Transducer Array Small - White
EUDAMEDClass IIb (EU MDR)
Ref ILE1010WEUModel ILE1010, ILE1010W, ILE1030, ILE1030WRef ILE2010WEU
Identity
- Trade Name
- ILE Transducer Array Small - White EUDAMED
- Device Name
- ILE Transducer Arrays EUDAMED
- Model / Reference
- ILE1010, ILE1010W, ILE1030, ILE1030W EUDAMEDILE1010WEU EUDAMEDILE2010WEU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107984133 EUDAMED07290107986175 EUDAMED
- Basic UDI-DI
- 0729010798402W8 EUDAMED0729010798376WY 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
ILE Transducer Array Small - White 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 | 0729010798402W8 | 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 e8990e09-7054-436b-82de-25fc5399e63b 61 fields · synced Jul 27, 2026
- EUDAMED 8f47a5a2-2e28-4270-a4d9-684491d9b252 61 fields · synced May 18, 2026