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Organization name
UDI-DI code
Reference / catalog number

SOpharmacy Sea Water Isotonic… — Class IIa MDR

MD Atlas
LABORATOIRES QUINTON INTERNATIONAL S.L.

EUDAMED last updated this device on Apr 17, 2026

SOpharmacy Sea Water Isotonic Nasal spray Baby 0+ 100ml

843700464900137

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABORATOIRES QUINTON INTERNATIONAL S.L.
UDI-DI code: 08437023259399
Reference / catalog number: PT431

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Manufacturer information

Organization name: LABORATOIRES QUINTON INTERNATIONAL S.L.
SRN: ES-MF-000004083
Manufacturer status: Active

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Critical warnings

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

CW139
Keep away from heat, sparks, open flames and hot surfaces.
CW268
Attention, pressurised container. May explode if heated. Do not perforate or burn, even after use
CW157
EUDAMED did not publish a description for this code.
CW999
The use of this product in other ENT pathologies has not been assessed. See your doctor if symptoms persist or differ from those described on the product. Do not use the product if you notice damage to the container, loss of pressure or if the solution is not released properly.
CW135
Keep out of the reach of children

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	Nov 10, 2025	Nov 1, 2029

Device identification

Trade name: SOpharmacy Sea Water Isotonic Nasal spray Baby 0+ 100ml
UDI-DI code: 08437023259399
Basic UDI-DI: 843700464900137
Reference / catalog number: PT431
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 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

Certificates

Certificate health across this manufacturer's portfolio.

2024 PR 0032Issued
Quality assuranceNotified body: 0318Expiry: Jul 21, 2029