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Neurologicalphysiotherapydevices -accessories
EUDAMEDFDA UDIClass I (EU MDR)
Ref AC3001Model P4080
Identity
- Trade Name
- NEUROLOGICALPHYSIOTHERAPYDEVICES -ACCESSORIES EUDAMEDROOVJOY FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Self-adhesive Electrode Pads EUDAMED
- Model / Reference
- P4080 EUDAMEDAC3001 EUDAMEDNeurological Therapy Devices Accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971763600100 EUDAMEDFDA UDI
- Basic UDI-DI
- 697176360PAD0001HT EUDAMED
- 510(k) Number
- K232995 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01028099 NEUROLOGICAL PHYSIOTHERAPY DEVICES - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Türkiye 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
Neurologicalphysiotherapydevices -accessories by Shenzhen Roundwhale Technology Co. Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697176360PAD0001HT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (3)
- EUDAMED 0cc8aed7-2658-4561-b36c-214858940569 61 fields · synced Jul 9, 2026
- FDA UDI f46ebef4-0b1e-47b0-be5b-5b0f142cea24 33 fields · synced May 25, 2026
- EUDAMED 3f516c6e-261e-48b6-a895-c16d5d7e525c 61 fields · synced Jul 9, 2026