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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

9801103000 — Class IIb MDR by Imaginalis Srl

MD Atlas
Imaginalis Srl

EUDAMED last updated this device on Oct 11, 2024

9801103000

80553857100103K

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Imaginalis Srl
UDI-DI code: 08055385710008
Reference / catalog number: 9801103000

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View device family (Basic UDI)

Manufacturer information

Organization name: Imaginalis Srl
SRN: IT-MF-000026523
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW028
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jul 19, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055385710008
Basic UDI-DI: 80553857100103K
Reference / catalog number: 9801103000
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: Device intended for computed tomography, digital radiography and fluoroscopy of human areas for clinical and intra-operative use
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)08055385710008

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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.

Z11030699COMPUTED TOMOGRAPHS (CT) - OTHER

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

980110400080553857100203NOn the market 980210100080553857100103KOn the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 1450769 1Amended
Quality management systemNotified body: 1936Expiry: Jul 18, 2029