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Organization name
UDI-DI code
Reference / catalog number

PL0115_100_Soft — Class IIa MDR by STE PHARMACEUTICALS,…

MD Atlas
STE PHARMACEUTICALS, S.L.U

EUDAMED last updated this device on Apr 28, 2026

PL0115_100_Soft

843654262PL01158Q

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STE PHARMACEUTICALS, S.L.U
UDI-DI code: 08436617642203
Reference / catalog number: PL0115_100_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	Oct 31, 2024	Dec 31, 2035

Device identification

Trade name: not provided
UDI-DI code: 08436617642203
Basic UDI-DI: 843654262PL01158Q
Reference / catalog number: PL0115_100_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: Isotonic sea water and aloe vera. It helps clean and hydrate the nasal mucous for babies, children and adults in daily nasal hygiene and improves moisturizing and relief from nasal discomfort.
Additional information URL: https://www.stepharmaceuticals.com/producto/free-nose-isotonic-sea-water-with-aloe-vera/
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