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QUCARE®Self Total Cholesterol
FDA UDIEUDAMEDRef 6407Model Blood Monitoring System
by Dfi Co., Ltd
Identity
- Trade Name
- QUCARE® Self Total cholesterol test strip EUDAMEDQUCARE®Self Total Cholesterol FDA UDI
- Generic Name
- Total cholesterol lipid IVD, reagent FDA UDI
- Device Name
- QUCARE Self Total Cholesterol Test strip EUDAMEDThe device is included 2 pouch FDA UDI
- Model / Reference
- 6407 EUDAMEDFDA UDIBlood Monitoring System EUDAMED
- Description
- The device is included 2 pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000015786VTCDY EUDAMED08806141302896 FDA UDI
- Basic UDI-DI
- B-KR-MF-000015786VTCDY EUDAMED
- EMDN Code
- W0101060102 CHOLESTEROL TEST STRIPS EUDAMED
- GMDN Term
- Total cholesterol lipid IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total cholesterol lipid IVD, reagent
QUCARE®Self Total Cholesterol by Dfi Co., Ltd — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) — Hearts Bio, Inc. · Class I
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dfi Co., Ltd
Sources (2)
- FDA UDI ff31ed3d-62cc-4a79-8e6b-c9a34229be2f 34 fields · synced Jul 13, 2026
- EUDAMED b605f88e-7075-4d35-ab7a-762ba933496c 61 fields · synced Jul 13, 2026