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C-Reactive Protein/Serum Amyloid A Reagent Kit

EUDAMED

Class IVD General (EU MDR)

Ref 1Z001Ref 12600783Model C-reactive Protein Quantitative Test Kit (Fluorescence Immunochromatography)

by Changsha Sinocare Inc.

Identity

Trade Name
C-Reactive Protein EUDAMED
Device Name
C-Reactive Protein/Serum Amyloid A Reagent Kit EUDAMED
C-reactive Protein Quantitative Test Kit (Fluorescence Immunochromatography) EUDAMED
Model / Reference
1Z001 EUDAMED
C-reactive Protein Quantitative Test Kit (Fluorescence Immunochromatography) EUDAMED
12600783 EUDAMED

Identifiers

Primary DI / UDI-DI
D-02B0010YC EUDAMED
06934175046270 EUDAMED
Basic UDI-DI
B-02B0010YC EUDAMED
B-06934175046270 EUDAMED
EMDN Code
W0102160601 C-REACTIVE PROTEIN - RT & POC EUDAMED
W01021109 C-REACTIVE PROTEIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands EUDAMED
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMEDEUDAMED

Near-Patient Testing

Yes

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

C-Reactive Protein/Serum Amyloid A Reagent Kit by Changsha Sinocare Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Changsha Sinocare Inc.
EUDAMED SRN
CN-MF-000012244
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (2)

  • EUDAMED 27375f95-df94-4d24-9926-767453433f8b 61 fields · synced Jul 26, 2026
  • EUDAMED 7603b6d6-6e13-41ec-bc9e-fc225c1ac1ed 61 fields · synced May 17, 2026