Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

BIOGENA Wellbeing Check | Omega-3… — IVDR Class A IVDR

MD Atlas
Cerascreen GmbH

EUDAMED last updated this device on Dec 17, 2025

BIOGENA Wellbeing Check | Omega-3 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: 04251620711609
Reference / catalog number: 99010628

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Cerascreen GmbH
SRN: DE-MF-000017602
Manufacturer status: Active

Related devices

9901003242516207002JROn the market 9901046942516207003JTOn the market 9901024542516207002JROn the market BIOGENA Wellbeing Check | Vitamin D Essential42516207002JROn the market BIOGENA Wellbeing Check Osteo Essential42516207003JTOn 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.

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 | Omega-3 Essential
UDI-DI code: 04251620711609
Basic UDI-DI: 42516207002JR
Reference / catalog number: 99010628
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 Omega-3 Essential ist ein Testkit zur einfachen Entnahme von Kapillarblut zuhause. Die eingesendete Probe wird in einem zertifizierten Diagnostiklabor analysiert. Dabei werden das Omega-6/3-Verhältnis sowie der prozentuale Anteil von Omega-3-Fettsäuren an den dominierenden Fettsäuren aus der Membran der Erythrozyten bestimmt.
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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification