Identity
- Trade Name
- Dario Smart Scale FDA UDI
- Generic Name
- Stand-on floor scale, electronic FDA UDI
- Device Name
- The Dario Smart Scale will accurately measure the weight of children and adults over 20 lbs. (9 kg). The maximum weight limit for the Dario Smart Scale is 396 lbs. (180 kg). FDA UDI
- Model / Reference
- 1166-05 FDA UDI
- Description
- The Dario Smart Scale will accurately measure the weight of children and adults over 20 lbs. (9 kg). The maximum weight limit for the Dario Smart Scale is 396 lbs. (180 kg). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850033352092 FDA UDI
- FDA Product Code
- FRI FDA UDI
- GMDN Term
- Stand-on floor scale, electronic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2700 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stand-on floor scale, electronic
Dario Smart Scale by Dariohealth Corp. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Dariohealth Corp.
Sources (1)
- FDA UDI 4d52e043-3431-4732-a5bf-bc44b40b2136 33 fields · synced May 30, 2026