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Singapore HSA registration DE0504446

Mdoloris ANI MOC-9

Singapore flagSingapore·CLASS B·MDOLORIS MEDICAL SYSTEMS SAS·Registered May 08, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0504446
Registration Date
May 08, 2020
Change Notification Approval Date
March 24, 2023
Retention Due Date
May 07, 2026
Product description
ANI MOC-9 is a non-invasive system intended to be used to monitor the tone of the parasympathetic nervous system. The electrocardiogram is intended to be used on conscious patients to reflect acute pain and the patient’ stress level. The Mdoloris Medical Module ANI MOC-9 and its sensors are designed to be used for adult and paediatric patients from the age of 12 years. ANI MOC-9 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use in a medical and non-sterile environment. ANI MOC-9 is intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the ANI index in conjunction with other available clinical signs. Reliance on ANI alone for interpreting analgesic management is not recommended
Product Owner
Name
MDOLORIS MEDICAL SYSTEMS SAS
Short Name
MDOLORIS MEDICAL SYSTEMS SAS
Address
Biocentre Fleming, Bâtiment C - Epi de Soil, 270, rue Salvador Allende, 59120 LOOS, FRANCE
Registrant
Name
OPTIMAL MEDICAL PRODUCTS PTE LTD
Address
33 UBI AVENUE 3, VERTEX, #01-27, SINGAPORE 408868
Importer
Name
OPTIMAL MEDICAL PRODUCTS PTE LTD
Address
33 UBI AVENUE 3, VERTEX, #01-27, SINGAPORE 408868
Model information
Model Name(s)
ANI MOC-9 ANI Sensor V1 PLUS
Model Identifier(s)
ANI MOC-9 ANI-SENS-V1PLUS
About this record

Access comprehensive regulatory information for Mdoloris ANI MOC-9 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504446 and owned by MDOLORIS MEDICAL SYSTEMS SAS. The device was registered on May 08, 2020.

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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