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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

NT01012 — IVDR Class B IVDR by DiaMex GmbH

MD Atlas
DiaMex GmbH

EUDAMED last updated this device on Nov 11, 2024

NT01012

426046567NTHBVScrCV

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DiaMex GmbH
UDI-DI code: 4260465670897
Reference / catalog number: NT01012

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Manufacturer information

Organization name: DiaMex GmbH
SRN: DE-MF-000037219
Manufacturer status: Active

Related devices

SR11013B-04260465670170On the market SR11011426046567SRBlueSFOn the market SR11019426046567SRBlueSFOn the market SR11013426046567SRBlueSFOn the market SR11019B-04260465670187On 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.

CW008
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 11, 2024	Still on market
Poland	Nov 11, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 4260465670897
Basic UDI-DI: 426046567NTHBVScrCV
Reference / catalog number: NT01012
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: Optitrol NAT HBV Screening
Additional information URL: https://eifu.diamex.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105080808ALL INFECTIOUS DISEASES CONTROLS - NAT

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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