Identity
- Trade Name
- REMI FDA UDI
- Generic Name
- Electroencephalography telemetric monitoring system FDA UDI
- Device Name
- REMI Tablet FDA UDI
- Model / Reference
- R001 FDA UDI
- Description
- REMI Tablet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08600053881650 FDA UDI
- 510(k) Number
- K203827 FDA UDI
- FDA Product Code
- OMC FDA UDIGXY FDA UDI
- GMDN Term
- Electroencephalography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI882.1320 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 |
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Manufacturer
- Manufacturer
- Epitel, Inc.
Sources (1)
- FDA UDI fe7dd9bc-670a-428c-a0b2-cd18eccc821f 35 fields · synced May 30, 2026