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Organization name
UDI-DI code
Reference / catalog number

PL0078_120 — Class IIa MDR by STE PHARMACEUTICALS,…

MD Atlas
STE PHARMACEUTICALS, S.L.U

EUDAMED last updated this device on Apr 28, 2026

PL0078_120

843654262PL00789B

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STE PHARMACEUTICALS, S.L.U
UDI-DI code: 08430469005025
Reference / catalog number: PL0078_120

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Manufacturer information

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

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	Apr 14, 2023	Dec 31, 2035

Device identification

Trade name: not provided
UDI-DI code: 08430469005025
Basic UDI-DI: 843654262PL00789B
Reference / catalog number: PL0078_120
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 with Aloe Vera, Chamomile and mint aroma for daily nasal hygiene and descongestion. It is a strong and effective natural decongestant that improves moisturizing and relief from stuffy nose discomfort thanks to Aloe Vera and Chamomile. The mint aroma provides a pleasant aroma and freshness. Indicated as a therapeutic adjuvant in some indications such as nasopharyngitis, rhinitis, obstructive sinusitis, nasal dryness, hoarseness and as adjuvant treatment in ENT disorders (Ear, nose, and throat infections) and pediatric treatments.
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.