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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

3000-1001 — IVDR Class B IVDR by Biokit S.A.

MD Atlas
Biokit S.A.

EUDAMED last updated this device on Feb 11, 2026

3000-1001

84269500016764Y

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: 08426950001676
Reference / catalog number: 3000-1001

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Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW999
The reagents contain sodium azide as a preservative. Azides may react with metal plumbing forming explosive components. Upon disposal, please flush abundantly with water.
CW999
WARNING: POTENTIALLY BIOLOGICAL RISK MATERIAL. Because no test method can offer complete assurance of the absence of infectious agents, the reagents should be handled carefully
CW167
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
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: 08426950001676
Basic UDI-DI: 84269500016764Y
Reference / catalog number: 3000-1001
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: monogen kit 50 tests
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105099003MONONUCLEOSIS (EBV) - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification