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Technolas ZYOPTIX Diagnostic Workstation - HSA Registration DE0006447

Access comprehensive regulatory information for Technolas ZYOPTIX Diagnostic Workstation in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006447 and owned by Technolas Perfect Vision GmbH. The device was registered on March 31, 2011.

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 C
DE0006447
Technolas ZYOPTIX Diagnostic Workstation
HSA Registration Number: DE0006447
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Product Description

The ZYOPTIX Diagnostic Workstation is a medical diagnostic system that comprises the two individual measuring devices ZYWAVE II Aberrometer and ORBSCAN IIz Anterior Segment Analyzer in a combined workspace. The measurements are performed without physical contact and are noninvasive. The ZYWAVE II Aberrometer is a precision optical instrument for measuring the wavefront deformation of the human eye. The wavefront deformation is used to determine the refractive errors of the human eye. The ORBSCAN IIz Anterior Segment Analyzer measures elevation and curvature on both the anterior and posterior surfaces of the cornea, full corneal pachymetry, white-to-white, anterior chamber depth and angle kappa. It is the diagnostic device to gather diagnostic data as a baseline for a personalized treatment with a TECHNOLAS 217z100 or 217z100P Excimer Laser within a Laser-Assisted In Situ Keratomileusis (LASIK) treatment.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
HSA Product Code
HSAMDC00108
HS Code
90185000
Registration Information
Registration Number
DE0006447
Registration Date
March 31, 2011
Retention Due Date
March 30, 2026
Product Owner
Short Name
Technolas
Address
Messerschmittstr. 1 + 3, 80992 Munich, GERMANY
Registrant
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Importer
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Model Information
Model Name(s)
ZYOPTIX Diagnostic Workstation
Model Identifier(s)
50001000