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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

01R0901 — IVDR Class C IVDR by Biokit S.A.

MD Atlas
Biokit S.A.

EUDAMED last updated this device on Oct 8, 2025

01R0901

8436003070153X2

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biokit S.A.
UDI-DI code: 00380740151027
Reference / catalog number: 01R0901

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Manufacturer information

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

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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW011
This product contains material derived from human urine. Human urine sourced from healthy adults has not been shown to be a source of infectious agents; however, it is recommended that this product, human specimens, and all consumables contaminated with potentially infectious materials be handled with precautions as specified in the OSHA Standard on Bloodborne Pathogens or other appropriate regional, national, and institutional biosafety guidelines.
CW999
Contains sodium azide.
CW116
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: 00380740151027
Basic UDI-DI: 8436003070153X2
Reference / catalog number: 01R0901
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Alinity c β2-Microglobulin Standard
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019099SPECIFIC PROTEINS - 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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