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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

0314 — IVDD — General IVDD by MEDIWISS ANALYTIC GmbH…

MD Atlas
MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik

EUDAMED last updated this device on Jan 27, 2026

0314

B-04251342603145

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik
UDI-DI code: 04251342603145
Reference / catalog number: 0314

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Manufacturer information

Organization name: MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik
SRN: DE-MF-000004992
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Siehe Gebrauchsanweisung Punkt 7 Warnung und Vorsichtsmaßnahmen (siehe auch zusätzliche Sicherheitshinweise)

Market distribution

Primary placement in Germany; available across 2 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: 04251342603145
Basic UDI-DI: B-04251342603145
Reference / catalog number: 0314
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: Der AllergyScreen®/AlleisaScreen® ist ein Immunoblot zur semi-quantitativen Bestimmung des in humanem Serum/Plasma zirkulierenden allergenspezifischen Immunglobulins E (IgE).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020205IMMUNOGLOBULIN E - SCREEN

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

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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.