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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

TESI.View — Class IIa MDR by O3 Enterprise srl

MD Atlas
O3 Enterprise srl

EUDAMED last updated this device on Jan 23, 2025

TESI.View

805750062VIEWFC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: O3 Enterprise srl
UDI-DI code: 08057500620209
Reference / catalog number: RELEASES-39

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View device family (Basic UDI)

Manufacturer information

Organization name: O3 Enterprise srl
SRN: IT-MF-000028709
Manufacturer status: Active

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		Still on market

Device identification

Trade name: TESI.View
UDI-DI code: 08057500620209
Basic UDI-DI: 805750062VIEWFC
Reference / catalog number: RELEASES-39
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: —
Additional information URL: https://zeeromed-user-manual.scrollhelp.site/manuali-utente/v1/?l=en
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)08057500620209

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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.

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

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Related devices

RELEASES-39805750062VIEWFCOn the market MeriConnect805750062VIEWFCOn the market O3IMS.View805750062VIEWFCOn the market WebScribe View805750062VIEWFCOn the market ZEEROmed View805750062VIEWFCOn the market

Certificates

Certificate health across this manufacturer's portfolio.

IT337663Issued
Quality management systemNotified body: 1370Expiry: Dec 1, 2029