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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

14.94SOFFIO — Class I MDR by VASSILLI S.R.L.

MD Atlas
VASSILLI S.R.L.

EUDAMED last updated this device on Jun 18, 2025

14.94SOFFIO

805527193Access013RJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VASSILLI S.R.L.
UDI-DI code: 08055271934747
Reference / catalog number: 14.94SOFFIO

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View device family (Basic UDI)

Manufacturer information

Organization name: VASSILLI S.R.L.
SRN: IT-MF-000033141
Manufacturer status: Active

Related devices

10.36B805527193Access006RMOn the market 10.44E805527193Access006RMOn the market 10.44XXL805527193Access006RMOn the market 10.48805527193Access006RMOn the market 10.48XXL805527193Access006RMOn the market

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: 08055271934747
Basic UDI-DI: 805527193Access013RJ
Reference / catalog number: 14.94SOFFIO
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

EMDN nomenclature code(s)

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

Y122409HANDRIMS AND ONE-ARM-DRIVE SYSTEMS

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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