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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

Igloo Reader Pro — IVDR Class A IVDR by Dx365 GmbH

MD Atlas
Dx365 GmbH

EUDAMED last updated this device on May 7, 2024

Igloo Reader Pro

426247918R-DAAN

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Dx365 GmbH
UDI-DI code: 04262479180034
Reference / catalog number: R-DA

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Manufacturer information

Organization name: Dx365 GmbH
SRN: DE-MF-000038389
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: Igloo Reader Pro
UDI-DI code: 04262479180034
Basic UDI-DI: 426247918R-DAAN
Reference / catalog number: R-DA
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://support.dx365.world/care
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0299IVD INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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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.