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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

4010 005000 — Class IIb MDR by Meditalia Industriale Srl

MD Atlas
Meditalia Industriale Srl

EUDAMED last updated this device on May 27, 2026

4010 005000

805848056Transfer49

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Meditalia Industriale Srl
UDI-DI code: 08058480560080
Reference / catalog number: 4010 005000

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View device family (Basic UDI)

Manufacturer information

Organization name: Meditalia Industriale Srl
SRN: IT-MF-000032344
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	May 31, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058480560080
Basic UDI-DI: 805848056Transfer49
Reference / catalog number: 4010 005000
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: I dispositivi medici Solutran®hemo Sistemi accessori appartengono alla linea di dispositivi medici denominata “Sistemi Accessori” del Fabbricante Meditalia Industriale S.r.l. Sono dispositivi medici costituiti da sistemi di sacche in PVC di diversi volumi, completi di tubi e raccordi, ognuno destinato ad una specifica attività relativa ad emocomponenti, come ad esempio: stoccaggio, trasferimento, conservazione e preparazione di emocomponenti. Nello specifico comprendono: 1. Sistema di sacche per trasferimento e stoccaggio di aliquote di: A. Piastrine B. Plasma C. Globuli rossi 2. Sacche singole per trasferimento e stoccaggio di: A. Piastrine B. Emocomponenti (Blood Components) C. Globuli rossi 3. Sistema per la preparazione di pool. A. Per crioprecipitato
Additional information URL: No additional information URL provided by the manufacturer.
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.

B010201WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

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.