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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

BIOGENA Wellbeing Check | Vitamin… — IVDR Class A IVDR

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Dec 17, 2025

BIOGENA Wellbeing Check | Vitamin D Essential

42516207002JR

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Cerascreen GmbH
UDI-DI code: 04251620711593
Reference / catalog number: 99010627

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Manufacturer information

Organization name: Cerascreen GmbH
SRN: DE-MF-000017602
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 Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Dec 22, 2025	Still on market
Germany	Dec 22, 2025	Still on market

Device identification

Trade name: BIOGENA Wellbeing Check | Vitamin D Essential
UDI-DI code: 04251620711593
Basic UDI-DI: 42516207002JR
Reference / catalog number: 99010627
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: Der BIOGENA Wellbeing Check Vitamin D Essential ist ein Testkit zur einfachen Entnahme von Kapillarblut zuhause. Die eingesendete Probe wird in einem zertifizierten Diagnostiklabor analysiert. Dabei wird der Vitamin-D-Spiegel über die Konzentration der Vitamin-D- Speicherform 25(OH)D3 im Blut ermittelt.
Additional information URL: https://biogena.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0501010201CAPILLARY BLOOD COLLECTION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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