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C-Reactive Protein (CRP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 126H40TRef 126H160TSCRef 126H40TSC
Identity
- Trade Name
- C-Reactive Protein (CRP) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- C-Reactive Protein (CRP) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 126H40T EUDAMED126H160TSC EUDAMED126H40TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-126H40T4X EUDAMEDD-126H160TSCLZ EUDAMEDD-126H40TSC4F EUDAMED
- Basic UDI-DI
- B-126H40T4X EUDAMEDB-126H160TSCLZ EUDAMEDB-126H40TSC4F EUDAMED
- EMDN Code
- W01021109 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
C-Reactive Protein (CRP) Assay Kit (Latex-enhanced Immunoturbidimetric Method) 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-126H40T4X | 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 0cee140b-ad75-4c0e-aa91-568cbc72949b 61 fields · synced Oct 6, 2026
- EUDAMED 7cbcdbca-3e21-4015-ad06-4cf6592d54d9 61 fields · synced May 16, 2026
- EUDAMED 23e8637d-258d-4423-9997-f2a65e5be7e1 61 fields · synced May 18, 2026