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Carl Zeiss Meditec Refractive Workplace - HSA Registration DE0508712

Access comprehensive regulatory information for Carl Zeiss Meditec Refractive Workplace in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508712 and owned by Carl Zeiss Meditec AG. The device was registered on December 01, 2023.

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
DE0508712
Carl Zeiss Meditec Refractive Workplace
HSA Registration Number: DE0508712
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Product Description

The Refractive Workplace (REFWP) is a software that accepts data from a data source (e.g. FORUM) intended to support an ophthalmic healthcare professional in assessing suitable treatment options for potential Laser Vision Correction (LVC) patients. It supports the treatment planning for the ZEISS refractive lasers. The application also uses diagnostic data for specific ZEISS refractive laser procedure types.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0508712
Registration Date
December 01, 2023
Change Notification Approval Date
April 03, 2025
Retention Due Date
November 30, 2025
Product Owner
Short Name
Carl Zeiss Meditec AG
Address
Goeschwitzer Strasse 51 - 52, 07745 Jena, GERMANY
Registrant
Address
80 BENDEMEER ROAD, #10-01, SINGAPORE 339949
Importer
Address
80 BENDEMEER ROAD, #10-01, SINGAPORE 339949
Model Information
Model Name(s)
Refractive Workplace
Model Identifier(s)
000000-2366-936