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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

8059575510003 — Class IIa MDR by EL.CO. S.r.l.

MD Atlas
EL.CO. S.r.l.

EUDAMED last updated this device on May 27, 2026

8059575510003

805957551FENIXSUITE20228C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EL.CO. S.r.l.
UDI-DI code: 08059575510003
Reference / catalog number: 8059575510003

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View device family (Basic UDI)

Manufacturer information

Organization name: EL.CO. S.r.l.
SRN: IT-MF-000029405
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Nov 29, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059575510003
Basic UDI-DI: 805957551FENIXSUITE20228C
Reference / catalog number: 8059575510003
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Version 1 of the Fenix DM certified according to the MDR regulation. This version offers all the features already present in the device previously certified according to Directive 93/42/EEC. A version 2 of the DM is available on the market (UDI: 08059575510010) with a new graphic design of the reporting console
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)08059575510003

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EMDN nomenclature code(s)

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

Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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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Related devices

8059575510010805957551FENIXSUITE20228COn 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.