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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

QC Cassette — IVDR Class A IVDR by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Dec 29, 2025

QC Cassette

6419587QC0010PV

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587351001
Reference / catalog number: 740480

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Manufacturer information

Organization name: Biohit Oyj
SRN: FI-MF-000014642
Manufacturer status: Active

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 Finland; available across 1 country total.

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

Device identification

Trade name: QC Cassette
UDI-DI code: 06419587351001
Basic UDI-DI: 6419587QC0010PV
Reference / catalog number: 740480
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: For verification of fluorescence reader performance (med/high). The QC cassette is a reusable accessory intended to verify the proper functioning and performance of the GP Reader NT (REF 740450) fluorescence immunoassay reader. The cassette provides a defined fluorescence signal response to confirm that the optical detection system of the instrument is operating as expected. This product is intended for use by healthcare professionals in laboratory or near-patient settings, as part of routine instrument performance verification. The device does not require any sample or specimen and does not have a medical function of its own.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201069080VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification

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