Identity
- Trade Name
- MyLink EUDAMED
- Device Name
- MyLink EUDAMED
- Model / Reference
- OTU5000 EUDAMEDOTU5000EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290107983518 EUDAMED
- Basic UDI-DI
- 0729010798351WG EUDAMED
- EMDN Code
- Z12040280 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
MyLink by Novocure GmbH — Class I — 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 | 0729010798351WG | Class I | Active |
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Manufacturer
- Manufacturer
- Novocure GmbH
- EUDAMED SRN
- CH-MF-000029002
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED e5631f10-a51e-4e20-bc30-efcf03fa417c 61 fields · synced Jun 18, 2026