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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

PL0033_120_Soft — Class IIa MDR by STE PHARMACEUTICALS,…

MD Atlas
STE PHARMACEUTICALS, S.L.U

EUDAMED last updated this device on Apr 28, 2026

PL0033_120_Soft

843654262PL00338M

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STE PHARMACEUTICALS, S.L.U
UDI-DI code: 08426420087285
Reference / catalog number: PL0033_120_Soft

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Manufacturer information

Organization name: STE PHARMACEUTICALS, S.L.U
SRN: ES-MF-000000144
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

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

CW010
Consult instructions for use

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Nov 23, 2023	Dec 31, 2035

Device identification

Trade name: not provided
UDI-DI code: 08426420087285
Basic UDI-DI: 843654262PL00338M
Reference / catalog number: PL0033_120_Soft
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: Hypertonic sea water for daily nasal hygiene and decongestion. It is indicated as a therapeutic adjuvant in some indications such as nasopharyngitis, allergic rhinitis, sinusitis, hoarseness, and ENT (ear, nose and throat) disorders and pediatric treatments.
Additional information URL: https://www.stepharmaceuticals.com/es/producto/free-nose-agua-de-mar-hipertonica/
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

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Software identification