Identity
- Trade Name
- REMI FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- REMI-Cloud FDA UDI
- Model / Reference
- 2.3 FDA UDI
- Description
- REMI-Cloud FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005388158 FDA UDI
- FDA Product Code
- OMC FDA UDI
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Remi by Epitel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epitel, Inc.
Sources (1)
- FDA UDI 0618d658-db34-4d9c-8991-fe0f062a957f 35 fields · synced Jun 6, 2026