Identity
- Trade Name
- CustomCare EUDAMEDFDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- E275/S21 Transcutaneous Electrical Nerve Stimulation (TENS) Device EUDAMED
- Model / Reference
- E275, S21 EUDAMEDS21 CustomCare EUDAMEDS21 FDA UDI
Identifiers
- Catalog Number
- MF-91 FDA UDI
- Primary DI / UDI-DI
- 00817076010846 EUDAMEDFDA UDI
- Basic UDI-DI
- 081707601TENSAY EUDAMED
- 510(k) Number
- K033253 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- EMDN Code
- Z120622 MUSCLE STIMULATORS 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
- 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CustomCare by Micro Current Technology, Inc. — Class IIa — 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 | 081707601TENSAY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 2301a38c-2138-46e8-b6b9-10654549f5cd 61 fields · synced Jul 15, 2026
- FDA UDI c209a96e-6627-4b69-b8ea-1a75ed0188eb 34 fields · synced May 29, 2026