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High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determinati…
EUDAMEDClass IVD General (EU MDR)
Ref 99H40TSCRef 99H240TSC
Identity
- Trade Name
- High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method) EUDAMED
- Device Name
- High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determination Method) EUDAMED
- Model / Reference
- 99H40TSC EUDAMED99H240TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-99H40TSCY2 EUDAMEDD-99H240TSCEU EUDAMED
- Basic UDI-DI
- B-99H40TSCY2 EUDAMEDB-99H240TSCEU EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Homogeneous Determinati… by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-99H40TSCY2 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 5e940fff-ff50-4e65-b456-362869ac26a6 61 fields · synced Sep 17, 2026
- EUDAMED ccba0652-b2af-413e-bb0d-998d6e118094 61 fields · synced May 19, 2026