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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

1022450 — IVDR Class A IVDR by Axon Biotech GmbH

MD Atlas
Axon Biotech GmbH

EUDAMED last updated this device on Aug 27, 2025

1022450

425173790265

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Axon Biotech GmbH
UDI-DI code: 04251737902495
Reference / catalog number: 1022450

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Manufacturer information

Organization name: Axon Biotech GmbH
SRN: DE-MF-000027334
Manufacturer status: Active

Related devices

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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.

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04251737902495
Basic UDI-DI: 425173790265
Reference / catalog number: 1022450
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 10
Additional product description: —
Additional information URL: https://www.axonbiotech.de/category/download-center/gebrauchsanweisungen
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010703URINE SCREENING MANUAL (DIPSLIDES ETC.)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
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Software identification