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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

10119 — Class I MDR by Pharmaflex S.r.l.

MD Atlas
Pharmaflex S.r.l.

EUDAMED last updated this device on Jul 31, 2023

10119

8050506750000GMEMORY01NA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pharmaflex S.r.l.
UDI-DI code: 08050506750055
Reference / catalog number: 10119

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View device family (Basic UDI)

Manufacturer information

Organization name: Pharmaflex S.r.l.
SRN: IT-MF-000036467
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

No critical warnings reported for this device.

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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: 08050506750055
Basic UDI-DI: 8050506750000GMEMORY01NA
Reference / catalog number: 10119
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Guanciale con fori di altezza 5 cm in grado di assolvere a 2 funzioni: - Funzione Anti-Plagiocefalia: Grazie alla precisa densità del nostro Safe-Disk (che abbiamo raggiunto solo dopo anni di studi e test), la testa del neonato viene accolta e la sua forma memorizzata dalle cellule che compongono la struttura del nostro innovativo materiale, questo garantisce anche un comfort unico per il piccolo. - Funzione Anti-soffocamento: Grazie al Safe-Disk, la testa del neonato è libera di muoversi e non viene trattenuta per tutto il tempo nella stessa posizione (come accade per i cuscini col buco). Infatti, è proprio il prolungato mantenimento di una sola posizione a provocare, nella maggior parte dei casi, fenomeni di plagiocefalia o brachicefalia. Ma soprattutto, in caso di rigurgito, il bambino è libero di muoversi evitando il soffocamento
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.

V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

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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