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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

13001209 — Class IIa MDR by Fidia Farmaceutici S.p.A.

MD Atlas
Fidia Farmaceutici S.p.A.

EUDAMED last updated this device on Apr 30, 2026

13001209

80336618006060100000000VV

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fidia Farmaceutici S.p.A.
UDI-DI code: 08055267242924
Reference / catalog number: 13001209

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View device family (Basic UDI)

Manufacturer information

Organization name: Fidia Farmaceutici S.p.A.
SRN: IT-MF-000026988
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

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

CW999
The product is for nasal use only
CW262
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW999
The product can be used up to 6 months after the first application
CW999
Do not discard the empty packaging in the environment and dispose according to applicable national practice.
CW999
Keep the box and the instructions for use for the entire period of use of the device.
CW007
EUDAMED did not publish a description for this code.
CW999
Keep out of the sight and reach of children.

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Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Mar 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055267242924
Basic UDI-DI: 80336618006060100000000VV
Reference / catalog number: 13001209
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 0.2 MU01
20 MU24

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.

Q030199NASOPHARYNGEAL 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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