Identity
- Trade Name
- Roger X (02) demo EUDAMED
- Device Name
- Wireless HA receivers EUDAMED
- Model / Reference
- 052-3488-X02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389188028 EUDAMED
- Basic UDI-DI
- 07612904WRASPQ EUDAMED
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Roger X (02) demo by Phonak AG — 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 | 07612904WRASPQ | Class I | Active |
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Manufacturer
- Manufacturer
- Phonak AG
- EUDAMED SRN
- CH-MF-000015960
- Authorised Representative
- Sonova Deutschland GmbH DE-AR-000006322
Sources (1)
- EUDAMED d63a64c3-7bb2-4189-b2bc-c815951b7904 61 fields · synced Jul 9, 2026