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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

EMS I9H1 P — Class IIb MDR by SIMAD S.R.L.

MD Atlas
SIMAD S.R.L.

EUDAMED last updated this device on Mar 11, 2026

EMS I9H1 P

805714374MOONRAYWF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SIMAD S.R.L.
UDI-DI code: 08057143741620
Reference / catalog number: EMS I9H1 P

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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

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

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: 08057143741620
Basic UDI-DI: 805714374MOONRAYWF
Reference / catalog number: EMS I9H1 P
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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