Vietnam MOH registration 240000347/PCBB-HCM

OCT Retinal Fluorescence Imaging Machine

VN: Máy chụp cắt lớp võng mạc OCT

Vietnam·Risk Class TTBYT Loại B·CIRRUS HD-OCT Model 6000·Flextronics Manufacturing (Singapore) Pte Ltd·Registered Feb 15, 2024

Registration details

Analysis ID: 240000347/PCBB-HCM
Submission ID: 000.00.19.H29-240130-0004
Product Type: CIRRUS HD-OCT Model 6000

Company information

Manufacturer: Flextronics Manufacturing (Singapore) Pte Ltd
Product Owner: Carl Zeiss Meditec, Inc.
Authorized Representative: CÔNG TY TNHH CARL ZEISS VIỆT NAM

Technical details

Intended Use: CIRRUS HD-OCT is indicated for in vivo visualization, axial cross-sectional imaging, and 3D imaging of the anterior and posterior segments of the eye.

Dates and status

Registration Date: Feb 15, 2024

About this record

Access comprehensive regulatory information for OCT Retinal Fluorescence Imaging Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000347/PCBB-HCM and manufactured by Flextronics Manufacturing (Singapore) Pte Ltd. The authorized representative in Vietnam is CÔNG TY TNHH CARL ZEISS VIỆT NAM.

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