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Organization name
UDI-DI code
Reference / catalog number

PL0116 — Class IIa MDR by STE PHARMACEUTICALS,…

MD Atlas
STE PHARMACEUTICALS, S.L.U

EUDAMED last updated this device on Apr 28, 2026

PL0116

843654262PL01168S

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STE PHARMACEUTICALS, S.L.U
UDI-DI code: 08436617648380
Reference / catalog number: PL0116

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Manufacturer information

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

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PL0079_BB843654262PL00799DOn the market PL0145_140843654262PL01458ZOn the market PL0146_140843654262PL014693On the market PLASP004843654262PL00ASPGCOn the market PLASP002843654262PL00ASPGCOn the market

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 Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Apr 30, 2026	Dec 31, 2035

Device identification

Trade name: not provided
UDI-DI code: 08436617648380
Basic UDI-DI: 843654262PL01168S
Reference / catalog number: PL0116
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: Nasal decongestant. Designed to aid ease pathological process that occur with nasal discharge, with improved moisturizing and relief from discomfort of a blocked nose. No rebound effect or drugs.
Additional information URL: https://www.stepharmaceuticals.com/producto/free-nose-deep-breath/
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
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Software identification