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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

BIOCHEMISTRY ANALYZER AX-300 — IVDR Class A IVDR by GMT SARL

MD Atlas
GMT SARL

EUDAMED last updated this device on May 12, 2026

BIOCHEMISTRY ANALYZER AX-300

3770028922AX000TC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GMT SARL
UDI-DI code: 03770028922130
Reference / catalog number: AX300

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Manufacturer information

Organization name: GMT SARL
SRN: FR-MF-000025248
Manufacturer status: Active

Critical warnings

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

CW999
Moving parts (Do not touch when operation)
CW008
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: BIOCHEMISTRY ANALYZER AX-300
UDI-DI code: 03770028922130
Basic UDI-DI: 3770028922AX000TC
Reference / catalog number: AX300
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: 1
Additional product description: —
Additional information URL: https://baliodiagnostics.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

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

Related devices

This device is not currently linked to any other device.

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.