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

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Organization name
UDI-DI code
Reference / catalog number

PT428 — Class IIa MDR by OKEAN ZALE S.L

MD Atlas
OKEAN ZALE S.L

EUDAMED last updated this device on Apr 17, 2026

PT428

843702651401DC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OKEAN ZALE S.L
UDI-DI code: 08718274580990
Reference / catalog number: PT428

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Manufacturer information

Organization name: OKEAN ZALE S.L
SRN: ES-MF-000036705
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW135
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW999
Gebruik het product niet als u merkt dat de container beschadigd is, er sprake is van drukverlies of als de oplossing niet juist vrijkomt.
CW999
Het gebruik van dit product voor andere KNO-aandoeningen is niet geëvalueerd. Raadpleeg uw arts als uw symptomen blijven bestaan of anders zijn dan de voor het product genoemde symptomen.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08718274580990
Basic UDI-DI: 843702651401DC
Reference / catalog number: PT428
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: —
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.