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Combo Electrotherapy Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R-C1Model Combo Electrotherapy DeviceRef R-C4A-RW3Ref R-C4CRef F100Ref R-C4DRef M101BRef R-C4A-RW1Ref R-C4D-U7Ref R-C101ERef R-C4A-AUS1Ref R-C3Ref R-C101JRef R-C101IRef R-C1-MEX1Ref R-C101FRef M100A-WH1Ref M102ARef R-C6Ref R-E1Ref R-C101ARef M101A
Identity
- Trade Name
- Combo Electrotherapy Device EUDAMEDROOVJOY FDA UDI
- Generic Name
- Transcutaneous electrical stimulation probe FDA UDI
- Device Name
- Combo Electrotherapy Device EUDAMED
- Model / Reference
- Combo Electrotherapy Device EUDAMEDR-C1 EUDAMEDR-C4A-RW3 EUDAMEDR-C4C EUDAMEDF100 EUDAMEDR-C4D EUDAMEDM101B EUDAMEDR-C4A-RW1 EUDAMEDR-C4D-U7 EUDAMEDR-C101E EUDAMEDR-C4A-AUS1 EUDAMEDR-C3 EUDAMEDR-C101J EUDAMEDR-C101I EUDAMEDR-C1-MEX1 EUDAMEDR-C101F EUDAMEDM100A-WH1 EUDAMEDM102A EUDAMEDM101A EUDAMEDFDA UDIR-C6 EUDAMEDR-E1 EUDAMEDR-C101A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763600018 EUDAMED06971763600841 EUDAMED06971763600315 EUDAMED06971763600650 EUDAMED06971763600698 EUDAMED06971763600452 EUDAMED06971763600803 EUDAMED06971763600766 EUDAMED06971763600537 EUDAMED06971763600827 EUDAMED06971763600261 EUDAMED06971763600896 EUDAMED06971763600575 EUDAMED06971763600797 EUDAMED06971763600544 EUDAMED06971763600865 EUDAMED06971763600469 EUDAMED06971763600612 EUDAMEDFDA UDI06971763600476 EUDAMED06971763600032 EUDAMED06971763600490 EUDAMED06971763600254 EUDAMED
- Basic UDI-DI
- 697176360CE000173 EUDAMED
- Direct Marketing DI
- 06971763600841 EUDAMED06971763600315 EUDAMED06971763600650 EUDAMED06971763600698 EUDAMED06971763600452 EUDAMED06971763600803 EUDAMED06971763600766 EUDAMED06971763600537 EUDAMED06971763600827 EUDAMED06971763600261 EUDAMED06971763600896 EUDAMED06971763600575 EUDAMED06971763600797 EUDAMED06971763600865 EUDAMED06971763600469 EUDAMED06971763600476 EUDAMED06971763600032 EUDAMED06971763600490 EUDAMED06971763600254 EUDAMED06971763600612 EUDAMED
- FDA Product Code
- NUH FDA UDIGZL FDA UDIIPF FDA UDINGX FDA UDI
- EMDN Code
- N010103 BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED EUDAMEDZ120622 MUSCLE STIMULATORS EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation probe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI882.1330 FDA UDI890.5850 FDA UDI
- Market of Registration
- Spain EUDAMEDNetherlands EUDAMEDPoland EUDAMEDIreland EUDAMEDTürkiye EUDAMEDSweden EUDAMEDFrance EUDAMEDGermany EUDAMEDDenmark 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
Yes
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 (23)
- EUDAMED c969a665-3438-402f-a27f-895b1c738d0a 61 fields · synced Sep 17, 2026
- EUDAMED efa18f6b-75ab-4867-b256-614b89c10b7e 61 fields · synced May 16, 2026
- EUDAMED eef81eaf-b206-4696-a6f1-f1c1ca953084 61 fields · synced May 16, 2026
- EUDAMED 3434bb90-de39-4442-bb56-d9573525ccd7 61 fields · synced May 16, 2026
- EUDAMED c6153bd3-fa2a-4b16-bc23-fb907e6833d2 61 fields · synced May 17, 2026
- EUDAMED 36e00d3c-6cb0-4f4e-970a-d271f817a15d 61 fields · synced May 17, 2026
- EUDAMED ab4380cd-9892-4605-a359-616fd41f49e4 61 fields · synced May 17, 2026
- EUDAMED 51c66616-df54-465b-843d-c6fb069c77c0 61 fields · synced May 17, 2026
- EUDAMED fc78504f-9044-4c0c-999b-94f1337c766f 61 fields · synced May 17, 2026
- EUDAMED 857a2128-9bab-4815-8c8c-96a705ee8430 61 fields · synced May 17, 2026
- EUDAMED 3649a0a5-19ea-4e44-9f2a-de7aa4e0fb4b 61 fields · synced May 17, 2026
- EUDAMED fd6825ab-997c-49b2-a72f-a13b0f7596de 61 fields · synced May 17, 2026
- EUDAMED d583cc23-0bcc-4df1-8027-384da4039d34 61 fields · synced May 18, 2026
- EUDAMED 2bf540c3-be58-4a88-b5ef-0cc21101132c 61 fields · synced May 18, 2026
- EUDAMED bdf7be29-daf7-47ef-a9e5-008380d48517 61 fields · synced May 18, 2026
- EUDAMED 09a72410-cca7-483b-a901-4b00da44924c 61 fields · synced May 18, 2026
- EUDAMED 32a93bc5-8f3a-4b46-953a-35f36443e4e1 61 fields · synced May 18, 2026
- FDA UDI 925a5904-bd0c-4eea-adaa-e61f9f469384 32 fields · synced May 29, 2026
- EUDAMED 03439be0-ee81-445f-af9f-c6e589bda1b0 61 fields · synced Jul 12, 2026
- EUDAMED 31c43448-1e1a-4f4f-b07f-51815aef8b21 61 fields · synced Jul 24, 2026
- EUDAMED 3fb6248c-0880-4268-9285-d98f8abab37b 61 fields · synced Jul 24, 2026
- EUDAMED 3fd1a7a8-6c10-4350-9e51-bd6eaae50bb6 61 fields · synced Jul 29, 2026
- EUDAMED e72b30f9-853f-4690-901a-d3b0da4811c9 61 fields · synced Sep 17, 2026