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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

Vitarmonyl spray nasal — Class IIa MDD by Laboratoire…

MD Atlas
Laboratoire d'Odonto-Stomatologie Thermal

EUDAMED last updated this device on Jun 16, 2025

Vitarmonyl spray nasal

B-PFHAV060038P

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-PFHAV060038P
Reference / catalog number: PFHAV06003

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Manufacturer information

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

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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.

Critical warnings

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

CW139
enir à l'écart de la chaleur, des surfaces chaudes, des étincelles, des flammes nues et de toute autre source d'inflammation.
CW135
Tenir hors de portée des enfants.
CW157
Récipient sous pression : peut éclater sous l'effet de la chaleur.Ne pas perforer, ni brûler, même après usage.
CW999
Contre-indication : Hypersensibilité à l'eau de mer et/ou à tout autre composant. Toute autre utilisation en dehors de l'usage prévu.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Dec 30, 2024	Jun 16, 2025

Device identification

Trade name: Vitarmonyl spray nasal
UDI-DI code: D-PFHAV060038P
Basic UDI-DI: B-PFHAV060038P
Reference / catalog number: PFHAV06003
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 isotonique à l'eau de mer, hygiène nasale quotidienne de l'enfant et de l'adulte
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