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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

5.90.23985 — Class IIb MDR by de Götzen S.r.l.

MD Atlas
de Götzen S.r.l.

EUDAMED last updated this device on Nov 27, 2024

5.90.23985

++D804590L2

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: de Götzen S.r.l.
UDI-DI code: *+D804590239850L*
Reference / catalog number: 5.90.23985

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View device family (Basic UDI)

Manufacturer information

Organization name: de Götzen S.r.l.
SRN: IT-MF-000013302
Manufacturer status: Active

Critical warnings

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

CW010
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 14, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: *+D804590239850L*
Basic UDI-DI: ++D804590L2
Reference / catalog number: 5.90.23985
Issuing entity: HIBCC

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: AC X-MIND 230V,SHORT CONE,NO BRACKET,NO WALL PLATE
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

EMDN nomenclature code(s)

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

Z1103040101EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY
Z1103040102EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY

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

W0900046++D804W10QFOn the market 5.93.23831 ++D804592L6On the market 5.93.23832 ++D804592L6On the market 5.92.23832++D804592L6On the market 5.92.23831++D804592L6On the market

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.