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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

AB0024 — IVDR Class B IVDR by APPOLON BIOTECK

MD Atlas
APPOLON BIOTECK

EUDAMED last updated this device on Nov 18, 2025

AB0024

376032282DINFSCFRRK

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: APPOLON BIOTECK
UDI-DI code: 03760322820072
Reference / catalog number: AB0024

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Manufacturer information

Organization name: APPOLON BIOTECK
SRN: FR-MF-000022234
Manufacturer status: Active

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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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Nov 18, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760322820072
Basic UDI-DI: 376032282DINFSCFRRK
Reference / catalog number: AB0024
Issuing entity: GS1

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: Multiplex Detection kit of SARS-CoV-2 / Influenza A and B / RSV A-B by RT-PCR
Additional information URL: https://www.appolonbioteck.qarad.eifu.online/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105070304INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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