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Penta Arzneimittel Rxolve® Ultra Eye Drops - HSA Registration DE0509854

Access comprehensive regulatory information for Penta Arzneimittel Rxolve® Ultra Eye Drops in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509854 and owned by Penta Arzneimittel GmbH. The device was registered on September 30, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509854
Penta Arzneimittel Rxolve® Ultra Eye Drops
HSA Registration Number: DE0509854
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Product Description

Rxolve® Ultra cares for and moisturises ocular surface and alleviates symptoms of dry eye syndrome (e.g. irritated, red, itchy, watery and/or very sensitive ocular surface) by forming a sterile, preservative-free, viscoelastic, clear protective film on the cornea without impairing visual performance. As a result, Rxolve® Ultra gives long- lasting relief, moisturising, and care from discomforts associated with: •mechanical stress, e.g. from wearing of hard or soft contact lenses, or ophthalmic diagnostic procedures •environmental stress, e.g. induced by air conditioning, wind or cold, dry air, or polluted air •extended work on the computer, microscopes, and driving •regular use of certain medicines •decreasing tears production with age •allergens such as pollen, animal hair, dust, etc. Rxolve® Ultra is also well-tolerated during long-term use. It is suitable for contact lens wearers. The contact lenses do not have to be removed during the application of the eye drops.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0509854
Registration Date
September 30, 2024
Change Notification Approval Date
April 07, 2025
Retention Due Date
September 29, 2025
Product Owner
Short Name
Penta Arzneimittel GmbH
Address
Werksstraße 3,, D-92551 Stulln,, GERMANY
Registrant
Address
1 COLEMAN STREET, THE ADELPHI, #08-01, SINGAPORE 179803
Importer
Address
1 COLEMAN STREET, THE ADELPHI, #08-01, SINGAPORE 179803
Model Information
Model Name(s)
RXOLVE® ULTRA EYE DROPS
Model Identifier(s)
RXOLVE ULTRA