Identity
- Trade Name
- Magnetic therapy device EUDAMED
- Device Name
- Magnetic therapy device EUDAMED
- Model / Reference
- R-M100 EUDAMEDR-M200D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763601121 EUDAMED
- Basic UDI-DI
- 697176360CE000275 EUDAMED
- EMDN Code
- Z120606 MAGNETOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Magnetic therapy device by Shenzhen Roundwhale Technology Co. Ltd. — Class IIa — 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 | 697176360CE000275 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Roundwhale Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021504
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0c0a3aea-0479-4b28-8d9d-38e924af0c67 61 fields · synced Jun 18, 2026