Identity
- Trade Name
- Rosie SmartMeter NFC Professional FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- Rosie SmartMeter NFC Professional Blood Glucose Meter FDA UDI
- Model / Reference
- AC-NFC Meter FDA UDI
- Description
- Rosie SmartMeter NFC Professional Blood Glucose Meter FDA UDI
Identifiers
- Catalog Number
- 3K-01-16003K FDA UDI
- Primary DI / UDI-DI
- 00868665000045 FDA UDI
- 510(k) Number
- K140150 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rosie SmartMeter NFC Professional by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140150 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hmd Biomedical, LLC
Sources (1)
- FDA UDI 4fe27720-b936-4971-aafe-0d41b1d01bed 36 fields · synced May 30, 2026