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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

KF190896 — IVDD — General IVDD by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on May 20, 2026

KF190896

B-04050598008731

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598008731
Reference / catalog number: KF190896

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Manufacturer information

Organization name: Immundiagnostik AG
SRN: DE-MF-000020905
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.

CW018
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 04050598008731
Basic UDI-DI: B-04050598008731
Reference / catalog number: KF190896
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 MutaPLATE® Cystic Fibrosis Real-Time PCR Kit is a molecular biology assay based on TaqMan technology for the examination of the F508del mutation in the Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) from genomic DNA. The examined variation is connected to the development of severe symptoms of Cystic Fibrosis (Mucoviscidosis).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010101CYSTIC FIBROSIS

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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