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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

P1505/PCE/LEN/IGN — Class I MDR by Storello Ausili SRL

MD Atlas
Storello Ausili SRL

EUDAMED last updated this device on Apr 30, 2026

P1505/PCE/LEN/IGN

805495381CONT_LETTOXJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Storello Ausili SRL
UDI-DI code: 08054953810874
Reference / catalog number: P1505/PCE/LEN/IGN

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View device family (Basic UDI)

Manufacturer information

Organization name: Storello Ausili SRL
SRN: IT-MF-000045673
Manufacturer status: Active

Critical warnings

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

CW011
Use only under supervision of trained healthcare personnel or caregiver. Not intended as a substitute for patient monitoring. Assess patient suitability before use; contraindicated in patients whose clinical condition is incompatible with restraint systems. Do not use if the device is damaged or improperly installed. Incorrect use may result in injury or compromise patient safety.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08054953810874
Basic UDI-DI: 805495381CONT_LETTOXJ
Reference / catalog number: P1505/PCE/LEN/IGN
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: —
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

UDI-DI DataMatrix

Encoded

(01)08054953810874

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

M030599IMMOBILISATION SYSTEMS AND 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.