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Organization name
UDI-DI code
Reference / catalog number

PL0130 — Class IIa MDR by STE PHARMACEUTICALS,…

MD Atlas
STE PHARMACEUTICALS, S.L.U

EUDAMED last updated this device on Apr 28, 2026

PL0130

843654262PL01308L

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STE PHARMACEUTICALS, S.L.U
UDI-DI code: 04062981005012
Reference / catalog number: PL0130

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Manufacturer information

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

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Critical warnings

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

CW010
Consult instructions for use

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Jun 20, 2024	Dec 31, 2035

Device identification

Trade name: not provided
UDI-DI code: 04062981005012
Basic UDI-DI: 843654262PL01308L
Reference / catalog number: PL0130
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: It is designed to prevention and treatment of dryness for its moisturizing effect. It hydrates and protects the dry nasal mucosa. It is recommended in situations that require the moisturizing of dry nasal mucosa as consequence of various causes such as rhinitis from flu, allergies, and dry nostrils after surgery, air conditioning and drug treatments.
Additional information URL: https://www.stepharmaceuticals.com/es/producto/freenosedexpanthenol/
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

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.