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High-Sensitivity C-Reactive Protein (Hs-CRP) Assay Kit (Latex Agglutination Met…
EUDAMEDClass IVD General (EU MDR)
Ref 116H160TSC
Identity
- Trade Name
- High-Sensitivity C-Reactive Protein (Hs-CRP) Assay Kit (Latex Agglutination Method) EUDAMED
- Device Name
- High-Sensitivity C-Reactive Protein (Hs-CRP) Assay Kit (Latex Agglutination Method) EUDAMED
- Model / Reference
- 116H160TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-116H160TSCLA EUDAMED
- Basic UDI-DI
- B-116H160TSCLA EUDAMED
- EMDN Code
- W01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN 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-Sensitivity C-Reactive Protein (Hs-CRP) Assay Kit (Latex Agglutination Met… 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-116H160TSCLA | 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 (1)
- EUDAMED 26b50989-1538-4863-8b30-0878c21a9385 61 fields · synced Oct 6, 2026