Identity
- Trade Name
- NuvoMed FDA UDI
- Generic Name
- Glucose analyser IVD, home-use FDA UDI
- Device Name
- Glucose Test Strip (Non-apps) FDA UDI
- Model / Reference
- NGS50-24/0726 FDA UDI
- Description
- Glucose Test Strip (Non-apps) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859811007261 FDA UDI
- 510(k) Number
- K153561 FDA UDI
- FDA Product Code
- LFR FDA UDINBW FDA UDI
- GMDN Term
- Glucose analyser IVD, home-use 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose analyser IVD, home-use
NuvoMed by Nuvomed Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153561 also covers:
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
- Nuvomed Inc
Sources (1)
- FDA UDI b3c82069-dae5-4d04-a788-fefb4bb949e6 34 fields · synced May 30, 2026