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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

KG194096 — IVDD — General IVDD by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on May 18, 2026

KG194096

B-04050598008335

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598008335
Reference / catalog number: KG194096

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Manufacturer information

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

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: 04050598008335
Basic UDI-DI: B-04050598008335
Reference / catalog number: KG194096
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 MutaPLEX® Borrelia/Rickettsia real time PCR kit is an assay for the detection of Borrelia burgdorferi sensu lato DNA and Rickettsia species DNA, extracted from biological specimens and ticks
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011699BACTERIOLOGY - NA REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification