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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

P70720008 — Class IIb MDR by CEFLA s.c.

MD Atlas
CEFLA s.c.

EUDAMED last updated this device on Oct 16, 2025

P70720008

803383793IMXRAYCTB001QS

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CEFLA s.c.
UDI-DI code: 08033837931379
Reference / catalog number: P70720008

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View device family (Basic UDI)

Manufacturer information

Organization name: CEFLA s.c.
SRN: IT-MF-000009228
Manufacturer status: Active

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Critical warnings

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

CW018
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	Apr 6, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08033837931379
Basic UDI-DI: 803383793IMXRAYCTB001QS
Reference / catalog number: P70720008
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: Computed tomograph using conebeam technology. It is intended for diagnostic use using geometric and radiological density information obtained from two- and three-dimensional images of anatomical details and objects in the area under examination. The device is capable of analysing the head, including the dento-maxillo-facial and otorhinolaryngological regions, the spine and the upper and lower limbs. This device can be used for radiographic investigations of prostheses, surgical templates and other diagnostic aids. It can be used in the following fields in particular: implantology, maxillofacial surgery, orthodontics, periodontology, endodontics, ENT, prosthetics and orthopaedics.
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)08033837931379

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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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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.