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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

SYNAPSE VALUE — Class IIa MDR by FUJIFILM HEALTHCARE…

MD Atlas
FUJIFILM HEALTHCARE ITALIA S.P.A.

EUDAMED last updated this device on Jun 5, 2024

SYNAPSE VALUE

805699280SYNAPSEVALUEKQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FUJIFILM HEALTHCARE ITALIA S.P.A.
UDI-DI code: 08056992800014
Reference / catalog number: SYNAPSE VALUE

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View device family (Basic UDI)

Manufacturer information

Organization name: FUJIFILM HEALTHCARE ITALIA S.P.A.
SRN: IT-MF-000029974
Manufacturer status: Active

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SYNAPSE DOSE805699280SYNAPSEDOSECEOn the market SYNAPSE VALUE805699280SYNAPSEVALUEKQOn the market SYNAPSE WORKFLOW ES805699280SYNAPSEWFESEQOn the market

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	Jun 5, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056992800014
Basic UDI-DI: 805699280SYNAPSEVALUEKQ
Reference / catalog number: SYNAPSE VALUE
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: SYNAPSE VALUE is a software medical device (MDSW) which, in the context of data flow management related to patients undergoing diagnostic imaging investigations or interventional procedures (from the patient's approach to the healthcare facility to the delivery of the report), involving the use of ionizing radiations, records the dosimetric indices and estimates the dose absorbed by the patients.
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)08056992800014

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Z119092VARIOUS BIOIMAGING AND RADIOTHERAPY 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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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.