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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

KSC2-AB69 — IVDD — General IVDD by APPOLON BIOTECK

MD Atlas
APPOLON BIOTECK

EUDAMED last updated this device on Aug 1, 2025

KSC2-AB69

B-KSC2-AB692F

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: APPOLON BIOTECK
UDI-DI code: D-KSC2-AB692F
Reference / catalog number: KSC2-AB69

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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.

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

Device identification

Trade name: not provided
UDI-DI code: D-KSC2-AB692F
Basic UDI-DI: B-KSC2-AB692F
Reference / catalog number: KSC2-AB69
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Qualitative detection of SARS-CoV-2 by RT-qPCR
Additional information URL: https://www.appolonbioteck.qarad.eifu.online/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105041106CORONAVIRUS - NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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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.