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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

3000-2339 — IVDD — General IVDD by Biokit S.A.

MD Atlas
Biokit S.A.

EUDAMED last updated this device on Mar 12, 2026

3000-2339

B-3000-2339DM

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biokit S.A.
UDI-DI code: D-3000-2339DM
Reference / catalog number: 3000-2339

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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

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

CW010
EUDAMED did not publish a description for this code.
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.
CW999
WARNING: POTENTIALLY BIOHAZARDOUS MATERIAL. Because no test method can offer complete assurance of the absence of infectious agents, this product should be handled with caution.

Market distribution

Primary placement in Spain; available across 2 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: D-3000-2339DM
Basic UDI-DI: B-3000-2339DM
Reference / catalog number: 3000-2339
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

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

EMDN nomenclature code(s)

W0102152006ANAEMIA RELATED/VITAMIN CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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Software identification