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ILE Transducer Array Large - Black
EUDAMEDClass IIb (EU MDR)
Ref ILE1030EUModel ILE1010, ILE1010W, ILE1030, ILE1030W
Identity
- Trade Name
- ILE Transducer Array Large - Black EUDAMED
- Device Name
- ILE Transducer Arrays EUDAMED
- Model / Reference
- ILE1010, ILE1010W, ILE1030, ILE1030W EUDAMEDILE1030EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107984140 EUDAMED
- Basic UDI-DI
- 0729010798402W8 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 Large - 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 | 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 (1)
- EUDAMED b8acc512-c134-46ad-8bd6-bff15917e918 61 fields · synced Jun 19, 2026