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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

IC2801 — IVDD — General IVDD by ImmuChrom GmbH

MD Atlas
ImmuChrom GmbH

EUDAMED last updated this device on Apr 29, 2026

IC2801

B-04260154632816

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ImmuChrom GmbH
UDI-DI code: 04260154632816
Reference / catalog number: IC2801

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Manufacturer information

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

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Critical warnings

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

CW263
Calibrator contain human plasma
CW265
Acidic solutions

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Sep 13, 2005	Still on market
Türkiye	Feb 20, 2007	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260154632816
Basic UDI-DI: B-04260154632816
Reference / catalog number: IC2801
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: HPLC testkit for the quantitative measurement of homocysteine in EDTA-plasma
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020614HOMOCYSTEINE

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.