EUDAMED last updated this device on Aug 12, 2026

CK-MB Rapid Quantitative Test

B-06975679490428

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 →: 06975679490428
Reference / catalog number: HU-RE-F07F044002

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.

CK-MB 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 Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: CK-MB 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 →: 06975679490428
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-06975679490428
Reference / catalog number: HU-RE-F07F044002
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 CK-MB Rapid Quantitative Test along with Multi-functional Analyzer is a fluorescence immunoassay for quantitative measurement of MB Isoenzyme of Creatine Kinase (CK-MB) in human whole blood, serum or plasma.
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)06975679490428

EMDN nomenclature code(s)

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

W01021311CREATINE KINASE - MB MASS (IC)

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 Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market

CK-MB Rapid Quantitative Test

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Market distribution

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Manufacturer information

Certificates covering this device

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Certificates