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Organization name
UDI-DI code
Reference / catalog number

IC3450 — IVDD — General IVDD by ImmuChrom GmbH

MD Atlas
ImmuChrom GmbH

EUDAMED last updated this device on Apr 24, 2026

IC3450

B-04260154633455

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ImmuChrom GmbH
UDI-DI code: 04260154633455
Reference / catalog number: IC3450

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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

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

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

CW263
Calibrator and controls
CW265
Mobile phase and internal standard contain organic solvents

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Feb 14, 2014	Still on market
Türkiye	Feb 27, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260154633455
Basic UDI-DI: B-04260154633455
Reference / catalog number: IC3450
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: LCMS testkit for the quatititative determination od 25-OH Vitamin D3 and 25-OH Vitamin D2 in serum (100 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)

W010206030925-HYDROXYVITAMIN D

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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