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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

Physiologica nez bouché — Class IIa MDD by Laboratoire…

MD Atlas
Laboratoire d'Odonto-Stomatologie Thermal

EUDAMED last updated this device on Mar 27, 2025

Physiologica nez bouché

B-PFLYO06018MD

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-PFLYO06018MD
Reference / catalog number: PFLYO06018

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Manufacturer information

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

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Critical warnings

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

CW007
i le boitier est endommagé ne pas utiliser le produit en raison d'un risque de contamination
CW040
EUDAMED did not publish a description for this code.
CW277
si les symptômes continuent au delà de 4 jours consulter l'avis d'un medecin ou pharmacien
CW139
EUDAMED did not publish a description for this code.
CW157
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW999
contre indications: Hypersensibilité à l'eau de mer et/ou autre composant
CW999
Tout autre utilisation en dehors de l'usage prévu est formellement contre indiquée
CW999
utilisation chez les enfants, les personnes âgées alitées et/ou handicapées: la position allongée sur le côté, tête légèrement relevée est conseillée. ne jamais effectuer un lavage de nez la tête penchée en arrière afin d'éviter une fausse route ou ingestion.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Aug 13, 2020	Mar 27, 2025

Device identification

Trade name: Physiologica nez bouché
UDI-DI code: D-PFLYO06018MD
Basic UDI-DI: B-PFLYO06018MD
Reference / catalog number: PFLYO06018
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: solution d'eau de mer hypertonique, contient des sels marins et des oligo-éléments naturels
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

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.