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cushion
EUDAMEDFDA UDIClass I (EU MDR)
Ref SH3132111Model SH2162，SO1662，SO7732，SA1141，SO7682，SO7162，SH2132，SH3132，SH2172， SH2732，SO4182，SO1161，SH5132，SA1161
Identity
- Trade Name
- AUVON FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- cushion EUDAMED
- Model / Reference
- SH2162，SO1662，SO7732，SA1141，SO7682，SO7162，SH2132，SH3132，SH2172， SH2732，SO4182，SO1161，SH5132，SA1161 EUDAMEDSH3132111 EUDAMEDTU3336 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010656334 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600106563A00013E EUDAMED
- 510(k) Number
- K230174 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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
MR Safe FDA UDI
cushion by Changsha Anxiang Medical Technology Co., LTD — Class I — 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 | 08600106563A00013E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changsha Anxiang Medical Technology Co., LTD
- EUDAMED SRN
- CN-MF-000045942
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 8310635e-37c5-4434-96b6-b3891a3ea59b 61 fields · synced Jun 19, 2026
- FDA UDI 65c22e00-6d42-4c0a-b5d3-9c72fb9f02bb 33 fields · synced May 30, 2026