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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

312960041 — Class IIa MDR by LETI Pharma, S.L.U.

MD Atlas
LETI Pharma, S.L.U.

EUDAMED last updated this device on Nov 6, 2025

312960041

8431166INTRANASALC9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LETI Pharma, S.L.U.
UDI-DI code: 08431166121452
Reference / catalog number: 312960041

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Manufacturer information

Organization name: LETI Pharma, S.L.U.
SRN: ES-MF-000011559
Manufacturer status: Active

Critical warnings

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

CW999
Por motivos higiénicos y para evitar la transmisión de agentes patógenos, se recomienda que cada tubo sea utilizado por una sola persona.
CW999
No utilizar en caso de alergia o hipersensibilidad a cualquiera de los componentes individuales del producto
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08431166121452
Basic UDI-DI: 8431166INTRANASALC9
Reference / catalog number: 312960041
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: Gel hidratante para o cuidado e proteção contra a secura da mucosa nasal. A sua fórmula específica e bioadesiva proporciona hidratação e proteção à mucosa nasal.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

3129600438431166INTRANASALC9On the market 312040028431166INTRANASALC9On 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.