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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

Troponin I test kit (6 tests) — IVDD — General IVDD

MD Atlas
EUROLyser Diagnostica GmbH

EUDAMED last updated this device on Nov 21, 2023

Troponin I test kit (6 tests)

B-ST0230D8

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: EUROLyser Diagnostica GmbH
UDI-DI code: D-ST0230D8
Reference / catalog number: ST0230

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Manufacturer information

Organization name: EUROLyser Diagnostica GmbH
SRN: AT-MF-000013746
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

Placed on the market in Austria; per-country availability dates not published.

Device identification

Trade name: Troponin I test kit (6 tests)
UDI-DI code: D-ST0230D8
Basic UDI-DI: B-ST0230D8
Reference / catalog number: ST0230
Issuing entity: EUDAMED

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: Troponin I test kit for quantitative in vitro determination of cardiac Troponin I on smart or CUBE laboratory photometer.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160703TROPONIN I/T - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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