Identity
- Trade Name
- HeartsCare C1 monitoring system FDA UDI
- Generic Name
- Total cholesterol lipid IVD, reagent FDA UDI
- Model / Reference
- TD-4289 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850014861049 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total cholesterol lipid IVD, reagent
HeartsCare C1 monitoring system by Hearts Bio, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, reagent.
- FORA — FORA CARE INC. · Class I
- OS-CHOL — PZ CORMAY Spółka Akcyjna · IVD General
- Cholesterol (CHOL) Assay Kit (Oxidase Method) — YHLO BIOTECH (NANJING) CO., LTD. · IVD General
- Teco Diagnostics Cholesterol TC-Matrix-480 — TECO DIAGNOSTICS · Class I
- DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
- Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General
- Total Cholesterol (TC) — Maccura Biotechnology Co., Ltd. · IVD General
- Teco Diagnostics Cholesterol TC Matrix — TECO DIAGNOSTICS · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Hearts Bio, Inc.
Sources (1)
- FDA UDI ac1da8d0-61bd-427a-9303-df23d90c9c4f 32 fields · synced May 30, 2026