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Technolas Zyoptix XP Microkeratome system - HSA Registration DE0006203

Access comprehensive regulatory information for Technolas Zyoptix XP Microkeratome system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006203 and owned by Technolas Perfect Vision GmbH. The device was registered on March 01, 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
DE0006203
Technolas Zyoptix XP Microkeratome system
HSA Registration Number: DE0006203
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Product Description

The Zyoptix XP Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. The Zyoptix XP Microkeratome allows for cutting a precise corneal flap of predetermined thickness and diameter.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0006203
Registration Date
March 01, 2011
Retention Due Date
February 28, 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 XP disposable blades Microkeratome Disposable Tubing Zyoptix XP Microkeratome Zyoptix XP Microkeratome Zyoptix XP disposable blades Microkeratome Disposable Tubing Zyoptix XP Microkeratome Zyoptix XP Microkeratome Zyoptix XP Tray & Motor Zyoptix XP Tray-TPV
Model Identifier(s)
507-0048 507-0063 507-7000-01 507-7000-02 5070048 5070063 507700001 507700002 ZXP1000 ZXP1000TPV