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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

CR1-2.X.Y — Class IIb MDR by Fondazione Toscana…

MD Atlas
Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica

EUDAMED last updated this device on May 7, 2026

CR1-2.X.Y

805516299CR1KC

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica
UDI-DI code: 80551629900814
Reference / catalog number: CR1-2.X.Y

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View device family (Basic UDI)

Manufacturer information

Organization name: Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica
SRN: IT-MF-000038599
Manufacturer status: Active

Critical warnings

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

CW010
Consultare il manuale utente per maggiori dettagli

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Mar 30, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 80551629900814
Basic UDI-DI: 805516299CR1KC
Reference / catalog number: CR1-2.X.Y
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: Cartella clinica elettronica
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)80551629900814

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EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

ITH 2493640 1Supplemented
Quality management systemNotified body: 1936Expiry: Jan 26, 2030