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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

PFATP06004 — Class IIa MDD by Laboratoire…

MD Atlas
Laboratoire d'Odonto-Stomatologie Thermal

EUDAMED last updated this device on Jun 13, 2025

PFATP06004

B-PFATP06004C9

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratoire d'Odonto-Stomatologie Thermal
UDI-DI code: D-PFATP06004C9
Reference / catalog number: PFATP06004

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Manufacturer information

Organization name: Laboratoire d'Odonto-Stomatologie Thermal
SRN: FR-MF-000011980
Manufacturer status: Active

Critical warnings

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

CW275
Si un medico le receta un medicamento nasal, use este spray antes de la aplicacion y no después.
CW007
Debido al riesgo de contaminaction no tuilice el productio si el envase esta danado.
CW135
Mantener fuera del alcance de los ninos.
CW139
Mantener alejado del calor, chispas, llams abiertas, superficies calientes y otras fuentes de ignicion.
CW157
No fumar, no perforar ni quemar incluso después de su uso
CW999
contra indicaciones: hipersensibilidad al agua de mar y/o cualquier outro componente. Se desaconseja cualquier otro uso que el previsto
CW032
No tuilice el producto tras la fecha de caducidad.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Mar 6, 2024	Jun 13, 2025
Portugal	Mar 6, 2024	Jun 13, 2025

Device identification

Trade name: not provided
UDI-DI code: D-PFATP06004C9
Basic UDI-DI: B-PFATP06004C9
Reference / catalog number: PFATP06004
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: spray nasal agua de mar solucion isotonica higiene 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)

Q030103NASAL IRRIGATION SOLUTIONS

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

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On 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.