Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

0097 — 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 28, 2026

0097

B-04251342600977

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: 04251342600977
Reference / catalog number: 0097

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

CCD-blocking solution42513426CCDSolutionY7On the market CCD-blocking solution42513426CCDSolutionY7On the market CCD-blocking solution42513426CCDSolutionY7On the market Panel 1B-04251342600014On the market Panel 1B-04251342603862On 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

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

CW010
Vedi manuale di istruzioni voce 7 Avvertenze e precauzioni (vedi anche INFORMAZIONI AGGIUNTIVE SULLA SICUREZZA)

Market distribution

Primary placement in Germany; available across 2 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: 04251342600977
Basic UDI-DI: B-04251342600977
Reference / catalog number: 0097
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: AllergyScreen®/AlleisaScreen® è un dosaggio immunoblot per la determinazione semi-quantitativa di immunoglobuline E (IgE) allergene-specifiche circolanti nel siero/plasma umano.
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