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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

5P83-02 — IVDR Class B IVDR by Biokit S.A.

MD Atlas
Biokit S.A.

EUDAMED last updated this device on Oct 8, 2025

5P83-02

8436003070290XD

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biokit S.A.
UDI-DI code: 00380740157432
Reference / catalog number: 5P83-02

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Manufacturer information

Organization name: Biokit S.A.
SRN: ES-MF-000002406
Manufacturer status: Active

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Critical warnings

8 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW011
This product contains human-sourced and/ or potentially infectious components. Refer to the CONTENTS section of this package insert. No known test method can offer complete assurance that products derived from human sources or inactivated microorganisms will not transmit infection. Therefore, all human-sourced materials should be considered potentially infectious. It is recommended that this product, human specimens, and all consumables contaminated with potentially infectious materials be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate regional, national, and institutional biosafety practices should be used for materials that contain, are suspected of containing, or are contaminated with infectious agents.
CW999
DANGER: Contains kanamycin sulfate.
CW096
EUDAMED did not publish a description for this code.
CW137
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW313
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 00380740157432
Basic UDI-DI: 8436003070290XD
Reference / catalog number: 5P83-02
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Lp(a) Calibrators
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102010405LIPOPROTEIN ( A )

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

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.