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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

5120002 — IVDR Class A IVDR by Biolife Italiana s.r.l.

MD Atlas
Biolife Italiana s.r.l.

EUDAMED last updated this device on Jan 12, 2026

5120002

805418713MEDIAFLASK0051E4

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biolife Italiana s.r.l.
UDI-DI code: 08054187137730
Reference / catalog number: 5120002

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View device family (Basic UDI)

Manufacturer information

Organization name: Biolife Italiana s.r.l.
SRN: IT-MF-000018174
Manufacturer status: Active

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Critical warnings

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

CW267
This culture medium contains raw materials of animal origin. The ante and post mortem controls of the animals and those during the production and distribution cycle of the raw materials, cannot completely guarantee that the product doesn’t contain any transmissible pathogen. Therefore, it is recommended that the product be treated as potentially infectious, and handled observing the usual specific precautions: do not ingest, inhale, or allow to come into contact with skin, eyes, mucous membranes. Download the TSE Statement from the website www.biolifeitaliana.it, describing the measures implemented by Biolife Italiana for the risk reduction linked to infectious animal diseases.
CW030
This product is a qualitative in vitro diagnostic, for professional use only; it is to be used by adequately trained and qualified laboratory personnel, observing approved biohazard precautions and aseptic techniques
CW007
Fragile, handle with care

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08054187137730
Basic UDI-DI: 805418713MEDIAFLASK0051E4
Reference / catalog number: 5120002
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: —
Additional information URL: https://www.biolifeitaliana.it/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0104010306CULTURE MEDIA IN BOTTLES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.