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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

Kit SAT — IVDR Class A IVDR by IGENOMIX SPAIN LAB S.L…

MD Atlas
IGENOMIX SPAIN LAB S.L UNIPERSONAL

EUDAMED last updated this device on Mar 25, 2026

Kit SAT

8437021231P2D8

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: IGENOMIX SPAIN LAB S.L UNIPERSONAL
UDI-DI code: 08437021231038
Reference / catalog number: P2002

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Manufacturer information

Organization name: IGENOMIX SPAIN LAB S.L UNIPERSONAL
SRN: ES-MF-000029287
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
This kit should only be used for transporting samples.

Market distribution

Primary placement in Spain; available across 3 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Italy		Still on market
Slovenia		Still on market

Device identification

Trade name: Kit SAT
UDI-DI code: 08437021231038
Basic UDI-DI: 8437021231P2D8
Reference / catalog number: P2002
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: This kit is intended for use in collection and preservation of samples until they arrive at Igenomix's facilities. These instructions are intended for medical workers. The kit will transport sperm samples. The materials included in this kit can only be used by medical professionals, always in medical settings. This is not a self-assessment kit. This kit is not automated.
Additional information URL: https://kits.igenomix.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019099SAMPLES COLLECTION DEVICES - OTHER

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

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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.