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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

SOFIA NOIRE — Class I MDR by VILGO

MD Atlas
VILGO

EUDAMED last updated this device on Dec 10, 2025

SOFIA NOIRE

361580SOFIACD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VILGO
UDI-DI code: 03615800000364
Reference / catalog number: 1020064S1

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Manufacturer information

Organization name: VILGO
SRN: FR-MF-000009712
Manufacturer status: Active

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2 - 80 cm3615802YFOn the market 2 - 87,5cm3615802YFOn the market 2 - 95cm3615802YFOn the market 3 - 80 cm3615803YHOn the market 3 - 87,5cm3615803YHOn 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.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: SOFIA NOIRE
UDI-DI code: 03615800000364
Basic UDI-DI: 361580SOFIACD
Reference / catalog number: 1020064S1
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: CANNE ANGLAISE REF SOFIA NOIR - ALUMINIUM EPOXY NOIR
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y12030601ELBOW CRUTCHES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification