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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

8059575510010 — 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

8059575510010

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: 08059575510010
Reference / catalog number: 8059575510010

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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	Apr 18, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059575510010
Basic UDI-DI: 805957551FENIXSUITE20228C
Reference / catalog number: 8059575510010
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 2 of the Fenix DM certified according to the MDR regulation Compared to version 1 of the DM (UDI: 8059575510003), the new version offers an additional graphic design of the reporting console that is completely configurable for each individual user of the system. Further information is available in the dedicated manual/brochure
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)08059575510010

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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

8059575510003805957551FENIXSUITE20228COn 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.