EUDAMED last updated this device on Aug 12, 2026

CRP (C-reactive protein) Rapid Quantitative Test

B-06975679490527

On the marketIVDD — General

Applicable legislation: —
Organization name: Hunan Ehome Health Technology Co., Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06975679490527
Reference / catalog number: HU-RE-F07F035002

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

CRP (C-reactive protein) Rapid Quantitative Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hunan Ehome Health Technology Co., Ltd.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: CRP (C-reactive protein) Rapid Quantitative Test
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06975679490527
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06975679490527
Reference / catalog number: HU-RE-F07F035002
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The CRP (C-reactive protein) Rapid Quantitative Test along with Multi-functional Analyzer is intended for in vitro quantitative determination of C-reactive protein (CRP) in human whole blood, serum or plasma. -Fluorescence immunoassay -Predict future cardiovascular diseases (CVD) -Diagnosis for infection and inflammation
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06975679490527

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01021109C-REACTIVE PROTEIN

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Refer to instruction manual/booklet

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	—	Still on market

CRP (C-reactive protein) Rapid Quantitative Test

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Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

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Market distribution

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Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

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Certificates covering this device

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