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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

Y9610 — IVDR Class B IVDR by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on Nov 12, 2025

Y9610

4050598IAInflamM5

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598012462
Reference / catalog number: Y9610

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Manufacturer information

Organization name: Immundiagnostik AG
SRN: DE-MF-000020905
Manufacturer status: Active

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Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW083
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04050598012462
Basic UDI-DI: 4050598IAInflamM5
Reference / catalog number: Y9610
Issuing entity: GS1

Classification

Risk category: IVDR Class B
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 IDK® TNFα ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative detection of TNFα (Tumor Necrosis Factor alpha) in human serum. The assay is an in vitro diagnostic medical device and intended to be used by professional users in a laboratory environment. It can be performed manually or using an automated platform. The assay serves as an aid in monitoring the course of inflammation in individuals with suspected TNFα-dependent conditions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030603TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.