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Magnetic therapy device
EUDAMEDClass IIa (EU MDR)
Ref R-M100BModel R-M100Ref R-M100ERef R-M200BRef R-M200ARef R-M100DRef R-M200F
Identity
- Trade Name
- Magnetic therapy device EUDAMED
- Device Name
- Magnetic therapy device EUDAMED
- Model / Reference
- R-M100 EUDAMEDR-M100B EUDAMEDR-M100E EUDAMEDR-M200B EUDAMEDR-M200A EUDAMEDR-M100D EUDAMEDR-M200F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763601053 EUDAMED06971763601084 EUDAMED06971763601107 EUDAMED06971763601091 EUDAMED06971763601077 EUDAMED06971763601145 EUDAMED06971763601039 EUDAMED
- Basic UDI-DI
- 697176360CE000275 EUDAMED
- EMDN Code
- Z120606 MAGNETOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDSweden EUDAMEDSpain EUDAMEDTürkiye EUDAMEDItaly 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 (7)
- EUDAMED e5cc75b9-25da-46a1-920f-0c2504b1dce3 61 fields · synced Jul 30, 2026
- EUDAMED 950f78fd-d52a-4ccb-ab1b-bd7fb5b31666 61 fields · synced May 16, 2026
- EUDAMED c7f63057-982d-4823-bc41-2881d96a4ca1 61 fields · synced May 16, 2026
- EUDAMED ccf16215-cdf8-4b66-a463-7e5423c043b9 61 fields · synced May 17, 2026
- EUDAMED b6367086-8be5-4e43-a08b-16f2e0354f5f 61 fields · synced May 18, 2026
- EUDAMED d17d8fe6-1fec-4122-92b0-f9eb50998ac5 61 fields · synced May 18, 2026
- EUDAMED f4616fcb-0337-45d1-a9d3-c8d8d33d3f92 61 fields · synced May 18, 2026