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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

0432388 — Class I MDR by Gabbiano S.p.A.

MD Atlas
Gabbiano S.p.A.

EUDAMED last updated this device on Apr 24, 2026

0432388

803256811M05290QF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Gabbiano S.p.A.
UDI-DI code: 08004161323888
Reference / catalog number: 0432388

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View device family (Basic UDI)

Manufacturer information

Organization name: Gabbiano S.p.A.
SRN: IT-MF-000020347
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.

CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Sep 1, 2023	Still on market
Spain	Sep 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08004161323888
Basic UDI-DI: 803256811M05290QF
Reference / catalog number: 0432388
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 2
Additional product description: Listos para usar y fáciles de utilizar, los conos auriculares Farmasan facilitan la extracción del tapón de cerumen en el oído. La combustión lenta favorece la expulsión gradual y natural del exceso de cerumen. Equipado con sistema de seguridad antigoteo para eliminar la caída de residuos de combustión y disco protector antillama.
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)08004161323888

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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.

Q03040299EAR IRRIGATION DEVICES - 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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