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Singapore HSA registration DE0503582

Edan F6/F9 Fetal & Maternal Monitor

Singapore flagSingapore·CLASS B·Edan Instruments, Inc·Registered September 09, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0503582
Registration Date
September 09, 2019
Retention Due Date
September 08, 2025
Product description
The F6/ F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. F6/F9 Fetal & Maternal Monitor provides non-Stress testing for pregnant women. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer.
Product Owner
Name
Edan Instruments, Inc
Short Name
Edan Instruments, Inc
Address
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, CHINA
Registrant
Name
MEDICARE (S) PTE LTD
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Importer
Name
MEDICARE (S) PTE LTD
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Model information
Model Name(s)
FHR Probe FHR Probe TOCO Transducer Edan F6 Fetal & Maternal Monitor Edan F9 Fetal & Maternal Monitor
Model Identifier(s)
02.01.210256011 02.01.210258011 02.01.210259012 F6 F9
About this record

Access comprehensive regulatory information for Edan F6/F9 Fetal & Maternal Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503582 and owned by Edan Instruments, Inc. The device was registered on September 09, 2019.

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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