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Singapore HSA registration DE0507561

Carl Zeiss Meditec CONVIVO

Singapore flagSingapore·CLASS D·Carl Zeiss Meditec AG·Registered December 01, 2022
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0507561
Registration Date
December 01, 2022
Change Notification Approval Date
February 01, 2024
Retention Due Date
November 30, 2025
Product description
The confocal endomicroscopy system (CEM) is designed to produce confocal in vivo laser scanning images of the inner microstructure of tissue. The system can be used during surgical procedures and must be used in direct contact with the tissue under examination. The purpose of the active part (confocal processor, scanner) is to create confocal in vivo laser image recordings of the inner microstructure of tissue. The purpose of the sterile sheath covering the non-sterile scanner probe is to form a sterile barrier between the probe and the tissue.
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)
ZEISS Sterile Sheath for CONVIVO CONVIVO
Model Identifier(s)
302732-0530-000 6918
About this record

Access comprehensive regulatory information for Carl Zeiss Meditec CONVIVO in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507561 and owned by Carl Zeiss Meditec AG. The device was registered on December 01, 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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