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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

701X0001, 701X0002, 701XB000 — Class IIa MDR by CEFLA s.c.

MD Atlas
CEFLA s.c.

EUDAMED last updated this device on Oct 31, 2025

701X0001, 701X0002, 701XB000

803383793IMXRAYINA001QX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CEFLA s.c.
UDI-DI code: 08033837936862
Reference / catalog number: 701X0001, 701X0002, 701XB000

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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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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.

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	Jun 30, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08033837936862
Basic UDI-DI: 803383793IMXRAYINA001QX
Reference / catalog number: 701X0001, 701X0002, 701XB000
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: Digital intraoral sensors intended for the acquisition of digital intraoral images when exposed to X-rays, for diagnostic radiographic examination of human dentition (teeth, jaw and oral structures).
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)08033837936862

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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.

Z11030480INSTRUMENTS FOR ENDORAL RADIOLOGY - CONSUMABLES

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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