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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

302 — Class I MDR by POVATEX DI PREITE VITA…

MD Atlas
POVATEX DI PREITE VITA E C. s.a.s.

EUDAMED last updated this device on Jun 16, 2023

302

805596519302H7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POVATEX DI PREITE VITA E C. s.a.s.
UDI-DI code: 08055965193023
Reference / catalog number: 302

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View device family (Basic UDI)

Manufacturer information

Organization name: POVATEX DI PREITE VITA E C. s.a.s.
SRN: IT-MF-000035313
Manufacturer status: Active

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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: 08055965193023
Basic UDI-DI: 805596519302H7
Reference / catalog number: 302
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: Divaricatore a mutandina per il trattamento dei casi di lievi displasie congenite dell'anca di neonati e bimbi, favorisce un'adeguata divaricazione delle anche in evoluzione, e, inoltre, facilita una loro corretta maturazione anche in presenza di eventuale ossificazione tardiva. MISURA 2: per bimbi con un peso da 6 kg fino a 9 kg (divaricazione indicativa di 16 cm) Materiali: Tessuto TNT 100% POLIPROPILENE SPUNDBONDED, grammatura 70 g /m2 - CLASSE I STANDARD OEKO TEX@ Polietilene espanso addizionato EVA- Sistema di chiusura a strappo (velcro) [IT]
Additional information URL: https://www.povatex.it/prodotto/mutandina-correttiva-gio/
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.

V0299NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER

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.