Identity
- Trade Name
- AutoCare EUDAMED
- Device Name
- E275/S21 Transcutaneous Electrical Nerve Stimulation (TENS) Device EUDAMED
- Model / Reference
- E275, S21 EUDAMEDE275 AutoCare EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817076012642 EUDAMED
- Basic UDI-DI
- 081707601TENSAY EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
AutoCare by Micro Current Technology, Inc. — Class IIa — 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 | K032653 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081707601TENSAY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micro Current Technology, Inc.
- EUDAMED SRN
- US-MF-000038330
- Authorised Representative
- BEXPERTISE SOLUTIONS, S.L. ES-AR-000026896
Sources (2)
- EUDAMED a42aee0c-d4bf-4fec-aefc-05a1c4204c0c 61 fields · synced Jul 23, 2026
- FDA 510(k) K032653 1 fields · synced May 18, 2026