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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

IC6410 — IVDD — General IVDD by ImmuChrom GmbH

MD Atlas
ImmuChrom GmbH

EUDAMED last updated this device on Mar 17, 2026

IC6410

B-04260154636418

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ImmuChrom GmbH
UDI-DI code: 04260154636418
Reference / catalog number: IC6410

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Manufacturer information

Organization name: ImmuChrom GmbH
SRN: DE-MF-000033427
Manufacturer status: Active

Related devices

IC7500B-04260154637507On the market IC3500B-04260154633509On the market IC6400B-04260154636401On the market IC6500B-04260154636500On the market IC1900B-04260154631901On the market

Critical warnings

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

CW263
Standards contain plasma
CW265
Stop solution contains sulphuric acid

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260154636418
Basic UDI-DI: B-04260154636418
Reference / catalog number: IC6410
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: ELISA testkit for the quantitative measurement of Anti-human tissue transglutaminase sIgA / IgA in stool (960 tests)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102100601TISSUE TRANSGLUTAMINASE ANTIBODIES

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.