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Combo Electrotherapy Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M100AModel Combo Electrotherapy Device
Identity
- Trade Name
- Combo Electrotherapy Device EUDAMEDROOVJOY FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Combo Electrotherapy Device EUDAMED
- Model / Reference
- Combo Electrotherapy Device EUDAMEDM100A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971763600605 EUDAMEDFDA UDI
- Basic UDI-DI
- 697176360CE000173 EUDAMED
- Direct Marketing DI
- 06971763600605 EUDAMED
- FDA Product Code
- NUH FDA UDINGX FDA UDIIPF FDA UDIGZJ FDA UDI
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Combo Electrotherapy Device by Shenzhen Roundwhale Technology Co. Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697176360CE000173 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 8659cc8a-34a8-4064-9fe0-416781a11881 61 fields · synced Jul 13, 2026
- FDA UDI 2fc5422e-e1f3-4d28-a731-244025a106ab 32 fields · synced May 25, 2026