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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

Pharmactiv Le spray nasal… — Class IIa MDD by Laboratoire…

MD Atlas
Laboratoire d'Odonto-Stomatologie Thermal

EUDAMED last updated this device on Aug 13, 2024

Pharmactiv Le spray nasal hypertonique

B-PFPHA060018H

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-PFPHA060018H
Reference / catalog number: PFPHA06001

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Manufacturer information

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

Critical warnings

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

CW007
Si vous observez que le flacon est endommagé ou percé, ne pas utiliser le produit en raison d'un risque de contamination.
CW040
Récipient sous pression: peut éclater sous l'effet de la chaleur
CW277
Si les symptômes persistent pendant plus de 4 jours, consultez votre médecin ou votre pharmacien.
CW999
Les sujets hypertendus ou insuffisants rénaux doivent tenir compte de l'apport en sel dans leur ration quotidienne, Ne pas utiliser en cas d'hypersensibilité à l'eau de mer

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 1, 2016	Aug 13, 2024

Device identification

Trade name: Pharmactiv Le spray nasal hypertonique
UDI-DI code: D-PFPHA060018H
Basic UDI-DI: B-PFPHA060018H
Reference / catalog number: PFPHA06001
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: —
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

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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.