Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

PL0032_100_Medium — Class IIa MDR by STE PHARMACEUTICALS,…

MD Atlas
STE PHARMACEUTICALS, S.L.U

EUDAMED last updated this device on Apr 28, 2026

PL0032_100_Medium

843654262PL00328K

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STE PHARMACEUTICALS, S.L.U
UDI-DI code: 08436617643385
Reference / catalog number: PL0032_100_Medium

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

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 Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jun 9, 2025	Dec 31, 2035

Device identification

Trade name: not provided
UDI-DI code: 08436617643385
Basic UDI-DI: 843654262PL00328K
Reference / catalog number: PL0032_100_Medium
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 for daily nasal hygiene. Indicated in daily nasal cleansing for prevention and as a therapeutic adjuvant in some indications such as nasopharyngitis, obstructive rhinitis, sinusitis and nasal dryness.
Additional information URL: https://www.stepharmaceuticals.com/producto/free-nose-isotonic-sea-water/
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