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Organization name
UDI-DI code
Reference / catalog number

PURESSENTIEL RESPIRATORY… — Class I MDD by LABORATOIRE…

MD Atlas
LABORATOIRE PURESSENTIEL IRELAND LIMITED

EUDAMED last updated this device on Apr 30, 2024

PURESSENTIEL RESPIRATORY PROTECTIVE NASAL SPRAY 20 ML

B-3701056801616SV

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABORATOIRE PURESSENTIEL IRELAND LIMITED
UDI-DI code: D-3701056801616SV
Reference / catalog number: 6235379

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Manufacturer information

Organization name: LABORATOIRE PURESSENTIEL IRELAND LIMITED
SRN: IE-MF-000015521
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Keep out of the reach and sight of children. Not recommended for children less than 3 years old, pregnant or breastfeeding women, or people with a hypersensitivity to Eucalyptus radiata. Not recommended for people with a prior history of convulsions or epileptic seizures.

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: PURESSENTIEL RESPIRATORY PROTECTIVE NASAL SPRAY 20 ML
UDI-DI code: D-3701056801616SV
Basic UDI-DI: B-3701056801616SV
Reference / catalog number: 6235379
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: PURESSENTIEL® RESPIRATORY PROTECTIVE NASAL SPRAY is intended for use daily throughout the allergy season. It forms a protective film against environmental and plant allergens. It acts locally in the nasal cavity and reduces symptoms of allergic rhinitis such as sneezing, nasal discharge, obstruction, etc. It moistens the nasal cavities, preserving their natural hydration. Immediate comfort & sensation of soothing freshness.
Additional information URL: https://fr.puressentiel.com/products/spray-nasal-protection-bio-respiratoire
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.