← Back to catalogue
Self-adhesive Electrode Pads
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref P4080510(k) K222252
Identity
- Trade Name
- Self-adhesive Electrode Pads EUDAMED
- Device Name
- Self-adhesive Electrode Pads EUDAMED
- Model / Reference
- P4080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763600902 EUDAMED
- Basic UDI-DI
- 697176360PAD0001HT EUDAMED
- EMDN Code
- N01028099 NEUROLOGICAL PHYSIOTHERAPY DEVICES - ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Self-adhesive Electrode Pads by Shenzhen Roundwhale Technology Co. Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222252 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697176360PAD0001HT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Roundwhale Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021504
- FDA Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 2e878ef3-362b-494b-ad36-ca01afa5fb51 85 fields · synced Jun 18, 2026
- FDA 510(k) K222252 1 fields · synced May 18, 2026