Identity
- Trade Name
- Clever Choice FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Device Name
- Clever Choice HD Blood Glucose meter. Uses HD Test Strips. Ideal for Diabetics FDA UDI
- Model / Reference
- HD Meter FDA UDI
- Description
- Clever Choice HD Blood Glucose meter. Uses HD Test Strips. Ideal for Diabetics FDA UDI
Identifiers
- Catalog Number
- 98302-0001-07 FDA UDI
- Primary DI / UDI-DI
- 00898302014081 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use/point-of-care blood glucose monitoring system IVD
Clever Choice by Simple Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Home-use/point-of-care blood glucose monitoring system IVD.
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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
- Simple Diagnostics
Sources (1)
- FDA UDI 364d952f-9273-4970-946b-eaafea25a418 34 fields · synced May 31, 2026