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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

PT385 — Class IIa MDR by OKEAN ZALE S.L

MD Atlas
OKEAN ZALE S.L

EUDAMED last updated this device on Jul 1, 2025

PT385

843702651401DC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OKEAN ZALE S.L
UDI-DI code: 08437026514006
Reference / catalog number: PT385

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Manufacturer information

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

Critical warnings

3 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
El uso de este producto en otras patologías ORL no ha sido evaluado. Consulte con su médico en caso de que los síntomas persistan o sean diferentes a los descritos en el producto. No utilice el producto si observa daños en el envase, pérdida de presión o si no se libera la solución de manera adecuada.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437026514006
Basic UDI-DI: 843702651401DC
Reference / catalog number: PT385
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)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

Certificate health across this manufacturer's portfolio.

2025 PR 0048Issued
Quality assuranceNotified body: 0318Expiry: Apr 14, 2030