Identity
- Trade Name
- Renpho Blood Glucose vial packed test strip FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- Renpho Blood Glucose vial packed test strip FDA UDI
- Model / Reference
- 3S-01-1400A3 FDA UDI
- Description
- Renpho Blood Glucose vial packed test strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711200722895 FDA UDI
- 510(k) Number
- K121433 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose IVD, kit, electrometry
Renpho Blood Glucose vial packed test strip by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, kit, electrometry.
- VivaGuard Ino — Able Diagnostics Inc · Class I
- TruePoint — OK BIOTECH CO., LTD. · Class II
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- Easy Talk Blood Glucose Testing Strips 25ct — HOME AIDE DIAGNOSTICS, INC. · Class II
- FORA — FORA CARE INC. · Class II
- OneTouch Ultra — Lifescan, Inc. · Class II
- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
- Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC. · Class II
Cleared under the same submission
K121433 also covers:
- FIA Salut CS06 — Hmd Biomedical, LLC
- FIA Salut foil packed test strip — Hmd Biomedical, LLC
- FIA Salut foil packed test strip(for SS) — Hmd Biomedical, LLC
- FIA Salut vial packed test strip — Hmd Biomedical, LLC
- FIA Salut vial packed test strip — Hmd Biomedical, LLC
- FIA Salut vial packed test strip — Hmd Biomedical, LLC
- FIA Salut vial packed test strip(for Elhenawy) — Hmd Biomedical, LLC
- FIA Salut vial packed test strip(for SS) — Hmd Biomedical, LLC
- FIA Salut vial packed test strip(for SS) — Hmd Biomedical, LLC
- Renpho Blood Glucose Monitoring System — 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 80cb5cf4-aeb0-469a-b57a-0102accad269 34 fields · synced May 30, 2026