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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

K 7999.RE — IVDR Class A IVDR by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on Apr 14, 2026

K 7999.RE

4050598IATUSASXN

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598017009
Reference / catalog number: K 7999.RE

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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: 04050598017009
Basic UDI-DI: 4050598IATUSASXN
Reference / catalog number: K 7999.RE
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: The stool sample preparation system IDK® Amino Extract described here, is an extraction device for stool samples, pre-filled with extraction buffer. The product is an in vitro diagnostic device and is suitable for use by professionals in a laboratory environment and for self-use by laypersons. It can be performed manually. The extraction device serves as a simplified method for the collection of a defined amount of stool, the storage of the stool and the preparation of stool samples for further use in diagnostic detection methods in the laboratory. The application of the stool sample preparation system IDK® Amino Extract is suitable for the sample preparation of stool samples for use in the fol-lowing Immundiagnostik ELISAs: • Serotonin (K 6881) / GABA (K 7009) / Tryptophan (K 7729) / Histamin (K 8213)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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