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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

DP350 — IVDR Class A IVDR by Diaglobal GmbH

MD Atlas
Diaglobal GmbH

EUDAMED last updated this device on Jun 24, 2025

DP350

426015249DP350V6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Diaglobal GmbH
UDI-DI code: 04260152490647
Reference / catalog number: DP350

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Manufacturer information

Organization name: Diaglobal GmbH
SRN: DE-MF-000032608
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260152490647
Basic UDI-DI: 426015249DP350V6
Reference / catalog number: DP350
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: Manual clinical chemistry analyzer used to quantitatively determine clinical chemistry analytes in human serum, plasma and other clinical specimen from patients of all ages and independent of gender. The device is used in combination with reagents designed for manual procedures to be used by qualified laboratory technicians.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02010199CHEMISTRY INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.