Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SYNAPSE DOSE — Class IIa MDR by FUJIFILM HEALTHCARE…

MD Atlas
FUJIFILM HEALTHCARE ITALIA S.P.A.

EUDAMED last updated this device on Jul 5, 2024

SYNAPSE DOSE

805699280SYNAPSEDOSECE

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: 08056992800007
Reference / catalog number: SYNAPSE DOSE

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jun 20, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056992800007
Basic UDI-DI: 805699280SYNAPSEDOSECE
Reference / catalog number: SYNAPSE DOSE
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 DOSE is a software medical device (MDSW) whose primary use is to record dosimetric indices and estimate the absorbed dose by patients undergoing diagnostic services or interventional procedures involving the use of ionizing radiation; SYNAPSE DOSE is a system that also allows dose monitoring over time (Radiation Dose Monitoring System, RDMS) in terms of acquisition parameters and exposure indices of imaging modalities that involve the use of ionizing radiation.
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)08056992800007

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas

Related devices

SYNAPSE VALUE805699280SYNAPSEVALUEKQOn the market SYNAPSE VALUE805699280SYNAPSEVALUEKQOn the market SYNAPSE WORKFLOW ES805699280SYNAPSEWFESEQOn 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.