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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

AB0023 — IVDR Class C IVDR by APPOLON BIOTECK

MD Atlas
APPOLON BIOTECK

EUDAMED last updated this device on Aug 1, 2025

AB0023

376032282CGENF2F5FW

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: APPOLON BIOTECK
UDI-DI code: 03760322820102
Reference / catalog number: AB0023

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Manufacturer information

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

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jul 21, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760322820102
Basic UDI-DI: 376032282CGENF2F5FW
Reference / catalog number: AB0023
Issuing entity: GS1

Classification

Risk category: IVDR Class C
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 FII/FV thrombophilia by real-time PCR
Additional information URL: https://www.appolonbioteck.qarad.eifu.online/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010115COMBINED FACTOR II / FACTOR V LEIDEN

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

AB0030376032282APAN2234KOn the market AB0038376032282APAN2234KOn the market AB0022376032282CGENHLAB27J6On the market MTL376032282APANMTLD8On the market AB0024376032282DINFSCFRRKOn 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.