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Weinert Fido Laser Applicator - HSA Registration DE0510187

Access comprehensive regulatory information for Weinert Fido Laser Applicator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510187 and owned by WEINERT Fiber Optics GmbH. The device was registered on December 30, 2024.

This page provides complete registration details including product owner information, registrant details, 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
DE0510187
Weinert Fido Laser Applicator
HSA Registration Number: DE0510187
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Product Description

The laser probes are accessories that transmit laser light for cutting and vaporizing soft tissues in contact and non-contact mode. The laser probes are intended for temporary invasive and non-invasive use during ophthalmological surgical procedures performed with a compatible laser source cleared for the desired application. The FIDO Laser Applicator may only be used in combination with the ExTra or ExTra II laser system. The laser probes are single-use and ETO-sterilized and delivered in sterile condition.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510187
Registration Date
December 30, 2024
Retention Due Date
December 29, 2025
Product Owner
Short Name
WEINERT Fiber Optics GmbH
Address
Nalepastr. 170-171, D-12459 Berlin, GERMANY
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model Information
Model Name(s)
Fido Laser Applicator
Model Identifier(s)
M270405S