Identity
- Trade Name
- Easy@Home blood glucose monitoring system FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- Easy@Home blood glucose monitoring system FDA UDI
- Model / Reference
- 3K-01-250037 FDA UDI
- Description
- Easy@Home blood glucose monitoring system FDA UDI
Identifiers
- Catalog Number
- 3K-01-250037 FDA UDI
- Primary DI / UDI-DI
- 00810038634746 FDA UDI
- 510(k) Number
- K182428 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose IVD, kit, electrometry 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose IVD, kit, electrometryGlucose monitoring system IVD, point-of-care
Easy@Home blood glucose monitoring system by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182428 also covers:
- Easy@Home Blood Glucose Test Strip — Hmd Biomedical, LLC
- FIA Biomed Precisa Blood Glucose Test Strip — Hmd Biomedical, LLC
- FIA Biomed Precisa Blood Glucose Test Strip — Hmd Biomedical, LLC
- FIA Biomed Precisa Blood Glucose Test Strip — Hmd Biomedical, LLC
- FIA Biomed Precisa blood glucose monitoring system — Hmd Biomedical, LLC
- FIA Biomed Precisa blood glucose monitoring system — Hmd Biomedical, LLC
- GlucoLeader Enhance Blood Glucose Monitoring System(BR/BMT) — Hmd Biomedical, LLC
- GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ) — Hmd Biomedical, LLC
- GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) — Hmd Biomedical, LLC
- GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) — Hmd Biomedical, LLC
- GlucoLeader Enhance Blood Glucose Test Strip(BR/VM) — Hmd Biomedical, LLC
- GlucoseLeader Enhance Blood Glucose Monitoring System(BR/VM) — Hmd Biomedical, LLC
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 b58f8940-2aaa-4c1b-a1a1-cdf3a1625c58 36 fields · synced May 31, 2026