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Cholesterol (CHOL) Assay Kit (Oxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref 101H50TSCRef 101H50TRef 101H200TSC
Identity
- Trade Name
- Cholesterol (CHOL) Assay Kit (Oxidase Method) EUDAMED
- Device Name
- Cholesterol (CHOL) Assay Kit (Oxidase Method) EUDAMED
- Model / Reference
- 101H50TSC EUDAMED101H50T EUDAMED101H200TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-101H50TSCYU EUDAMEDD-101H50T2K EUDAMEDD-101H200TSCEX EUDAMED
- Basic UDI-DI
- B-101H50TSCYU EUDAMEDB-101H50T2K EUDAMEDB-101H200TSCEX EUDAMED
- EMDN Code
- W01010205 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
Category: Total cholesterol lipid IVD, reagent
Cholesterol (CHOL) Assay Kit (Oxidase Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-101H50TSCYU | 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 (3)
- EUDAMED 622159df-bb68-4dc5-bf13-e09aeffc592b 61 fields · synced Jul 9, 2026
- EUDAMED 08235bdc-fef7-4859-bd9e-86ee215e1294 61 fields · synced May 17, 2026
- EUDAMED 3bc463e6-8e5e-42e0-b357-56d3f5f2ed0d 61 fields · synced May 17, 2026