Identity
- Trade Name
- STIM-PRO Comfort+ EUDAMEDAxion FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- AXION TENS Devices EUDAMED
- Model / Reference
- 1023 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260280181318 EUDAMEDFDA UDI
- Basic UDI-DI
- 426028018TENS9B EUDAMED
- Direct Marketing DI
- 04260280181318 EUDAMED
- FDA Product Code
- GZJ FDA UDI
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Analgesic transcutaneous electrical nerve stimulation system
Axion by Axion Usa Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Axion Usa Llc
Sources (2)
- FDA UDI 6cb3c433-d0bb-440c-ac30-69d5696b7234 33 fields · synced Jun 19, 2026
- EUDAMED 8396951b-a3c4-41e2-bcee-f2e46d58fc1c 61 fields · synced Jun 19, 2026