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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

PFATP06003 — Class IIa MDD by Laboratoire…

MD Atlas
Laboratoire d'Odonto-Stomatologie Thermal

EUDAMED last updated this device on Mar 27, 2026

PFATP06003

B-PFATP06003C7

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-PFATP06003C7
Reference / catalog number: PFATP06003

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Manufacturer information

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

Related devices

PFATP06009B-PFATP06009CKOn the market AquadermaB-PFAQU06004CPOn the market PFATP06002B-PFATP06002C5On the market BIOLANE spray nasal isotonic 100mlB-PFBIO060036JOn the market Careway spray nasal hypertonique 100 mlB-PFCEL060033SOn 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.

Critical warnings

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

CW275
Si un medico le prescribe un medicamento nasal, utilice nuestro spray antes de la aplicacion y despues del tratamiento prescrito.
CW007
No utilizar el producto si el envase esta danado debido al riesgo de contaminacion
CW032
No utilizar cuando haya pasado la fecha de caducidad
CW139
Mantener alejado del calor, chispas, llamas, superficies calientes y otras fuentes de ignicion
CW157
No fumar no perforar ni quemar incluso después de usado
CW277
Si los sintomas persisten durante mas de 4 dias, consulte a su médico o farmaceutico
CW999
contraindicaciones: hipersensibilidad al agua de mar y/o cualquier otro componente. Cualquier caso no descrito en las indocaciones.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Oct 4, 2024	Jun 13, 2025

Device identification

Trade name: not provided
UDI-DI code: D-PFATP06003C7
Basic UDI-DI: B-PFATP06003C7
Reference / catalog number: PFATP06003
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: solucion isotonica de agua de mar del océano atlantico para la higiene de la nariz. Apto para bebés desde las dos semanas de edad
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