EUDAMED last updated this device on Sep 25, 2026

Internal Standard Set

B-04250317542359

On the marketIVDD — General

Applicable legislation: —
Organization name: Chromsystems Instruments + Chemicals GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04250317542359
Reference / catalog number: 96046

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Internal Standard Set is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chromsystems Instruments + Chemicals GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Internal Standard Set
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04250317542359
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-04250317542359
Reference / catalog number: 96046
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://chromsystems.com/en
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04250317542359

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0101050399CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 5 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market

Internal Standard Set

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Market distribution

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Manufacturer information

Certificates

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Certificates covering this device