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Singapore HSA registration DE0507474

Carl Zeiss VISUMAX

Singapore flagSingapore·CLASS C·Carl Zeiss Meditec AG·Registered November 11, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0507474
Registration Date
November 11, 2022
Change Notification Approval Date
January 15, 2025
Retention Due Date
November 10, 2025
Product description
The device is intended for use in ophthalmic surgery to make lamellar and penetrating corneal incisions. The device is indicated for (i) use in creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (ii) refractive corrections by creating and then surgically removing intrastromal lenticules; (iii) penetrating and lamellar keratoplasty; (iv) surgical treatment requiring an initial corneal incision.
Product Owner
Name
Carl Zeiss Meditec AG
Short Name
Carl Zeiss Meditec AG
Address
Goeschwitzer Strasse 51 - 52, 07745 Jena, GERMANY
Registrant
Name
CARL ZEISS PTE. LTD.
Address
80 BENDEMEER ROAD, #10-01, SINGAPORE 339949
Importer
Name
CARL ZEISS PTE. LTD.
Address
80 BENDEMEER ROAD, #10-01, SINGAPORE 339949
Model information
Model Name(s)
VISUMAX 600 VISUMAX 800 Treatment Pack Size S Treatment Pack Size M Treatment Pack Size L Treatment Pack Size KP
Model Identifier(s)
9510 9511 1013 1014 1015 1016
About this record

Access comprehensive regulatory information for Carl Zeiss VISUMAX in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507474 and owned by Carl Zeiss Meditec AG. The device was registered on November 11, 2022.

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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