OKEAN ZALE S.L

Okean Zale S.L specialises in nasal spray devices, including isotonic and hypertonic formulations. Their portfolio covers products like sinus irrigation sprays, nasal hygiene solutions, and baby-specific nasal sprays for congestion relief. These devices are designed for direct application in the nasal cavity to support hygiene, congestion relief, or sinus care.

Okean Zale S.L is based in Spain, where its medical devices are subject to the European Union’s regulatory framework. Since the company’s products fall under the EU Medical Device Regulation (MDR), they must comply with EU-wide requirements for safety, performance, and conformity assessment.

Okean Zale S.L’s devices are listed in the EUDAMED database, which is the official European Union database for medical devices. This registry tracks device information, including manufacturer details, technical documentation, and regulatory status, ensuring transparency and traceability under EU MDR.

Okean Zale S.L’s nasal sprays are classified as Class IIa medical devices under the EU Medical Device Regulation (MDR). This classification is determined by factors like the intended purpose (e.g., nasal hygiene or congestion relief) and the level of risk associated with their use. Class IIa devices require additional scrutiny, such as clinical evaluations or conformity assessments, to ensure safety and performance before market placement.