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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Diagnostic Kit for Cardiac… — IVDD — General IVDD

MD Atlas
MP Biomedicals Germany GmbH

EUDAMED last updated this device on May 22, 2026

Diagnostic Kit for Cardiac Troponin I

B-04260163315731

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: MP Biomedicals Germany GmbH
UDI-DI code: 04260163315731
Reference / catalog number: 07CTN15025

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View device family (Basic UDI)

Manufacturer information

Organization name: MP Biomedicals Germany GmbH
SRN: DE-MF-000020991
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Diagnostic Kit for Cardiac Troponin I
UDI-DI code: 04260163315731
Basic UDI-DI: B-04260163315731
Reference / catalog number: 07CTN15025
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Cardiac Troponin I Test Cassette is a fluorescence immunoassay for the quantitative determination of cardiac Troponin I (cTnI) in human whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction and cardiac injury.
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)04260163315731

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EMDN nomenclature code(s)

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

W0102160703TROPONIN I/T - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.