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Organization name
UDI-DI code
Reference / catalog number

4911002200 — Class IIb MDR by Meditalia Industriale Srl

MD Atlas
Meditalia Industriale Srl

EUDAMED last updated this device on May 26, 2026

4911002200

805848056CordSH

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Meditalia Industriale Srl
UDI-DI code: 08058480560004
Reference / catalog number: 4911002200

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View device family (Basic UDI)

Manufacturer information

Organization name: Meditalia Industriale Srl
SRN: IT-MF-000032344
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

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: 08058480560004
Basic UDI-DI: 805848056CordSH
Reference / catalog number: 4911002200
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: Il dispositivo medico Solutran®Hemo BioNest System appartiene alla linea di dispositivi medici denominata “Solutran®Hemo BioNest” del Fabbricante Meditalia Industriale S.r.l. Sono dispositivi medici costituiti da una o più sacche in PVC, collegate fra loro da tubi di connessione, destinati alla raccolta, conservazione o trasformazione degli emocomponenti ottenuti dal sangue del cordone ombelicale (cord blood-CB). Sono dispositivi sterili e monouso. Il dispositivo medico Solutran®hemo BioNest System è destinato alla produzione, alla raccolta e allo stoccaggio di concentrato piastrinico e plasma povero di piastrine (PPP), ottenuti da sangue intero. Il sistema è costituito da tre sacche in PVC (DEHP free, eccetto che per la sacca A), denominate rispettivamente “A”, “B” e “C”, collegate fra loro da tubi di connessione e destinate alla raccolta di concentrato piastrinico.
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.

B019001PLATELET GEL AND FIBRIN GLUE PRODUCTION 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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