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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

EM2 I9L1 G — Class IIb MDR by SIMAD S.R.L.

MD Atlas
SIMAD S.R.L.

EUDAMED last updated this device on Mar 11, 2026

EM2 I9L1 G

805714374MOONRAYWF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SIMAD S.R.L.
UDI-DI code: 08057143741552
Reference / catalog number: EM2 I9L1 G

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View device family (Basic UDI)

Manufacturer information

Organization name: SIMAD S.R.L.
SRN: IT-MF-000027245
Manufacturer status: Active

Related devices

EMS F3H2 P805714374MOONRAYWFOn the market EMS F3H2 V805714374MOONRAYWFOn the market EMS F3H1 G805714374MOONRAYWFOn the market EMS F3H2 G805714374MOONRAYWFOn the market EMS F3H1 P805714374MOONRAYWFOn the market

Critical warnings

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

CW010
Il dispositivo emette radiazioni ionizzanti. L'esposizione del paziente deve essere ridotta al minimo e gestita secondo le normative di radioprotezione applicabili. È richiesta particolare cautela in caso di pazienti pediatrici o in gravidanza. Il dispositivo deve essere utilizzato esclusivamente da personale formato e in conformità alle istruzioni per l'uso.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Sep 13, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08057143741552
Basic UDI-DI: 805714374MOONRAYWF
Reference / catalog number: EM2 I9L1 G
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Il dispositivo di fluoroscopia mobile Moonray è destinato a fornire immagini fluoroscopiche e digitali di popolazioni adulte e pediatriche durante procedure diagnostiche, interventistiche e chirurgiche.
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.

Z11039017MOBILE RADIOSCOPIC UNITS

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.