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Empatica Health Monitoring Platform
FDA UDIClass II (US FDA UDI)
by Empatica Srl
Identity
- Trade Name
- Empatica Health Monitoring Platform FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
- Model / Reference
- Care Portal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853858006263 FDA UDI
- 510(k) Number
- K221282 FDA UDI
- FDA Product Code
- DQA FDA UDILEL FDA UDIFLL FDA UDIGZO FDA UDIDRG FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI882.5050 FDA UDI880.2910 FDA UDI882.1540 FDA UDI870.2910 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple vital physiological parameter monitoring system, home-use
Empatica Health Monitoring Platform by Empatica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Empatica Srl
Sources (1)
- FDA UDI c56aec7d-c467-4e71-a46a-a784d54d9348 33 fields · synced Jun 8, 2026