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DEVICE DETAILS

NAME OF DEVICEULTRAFORMER III
ESTABLISHMENT NAMEIDS MEDICAL SYSTEMS (M) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB5454723-151679
BRAND NAMEULTRAFORMER III/CLASYS
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe ULTRAFORMER III is a non-invasive equipment. It is typically computer-controlled and is capable of producing localized heat within tissues or organs. Energy delivered to the patient is via an externally-mounted transducer. It is a safe and effective device for the treatment of dermatologic diseases. The life cycle of ULTRAFORMER III is 5 years
DEVICE INTENDED PURPOSE“ULTRAFORMER III (UF3-M300)” is a non-invasive therapeutic device for the treatment of ptosis, axillary hyperhidrosis and correction of skin laxity using the principle of coagulation and necrosis
VALIDITY DATE OF REGISTRATION05/10/2023 - 04/10/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1ULTRAFORMER III (Main Body)UF3000001
2Hand-piece ASSYUFH000002
3L4-4.5UFC344501
4L7-3.0UFC373001
5L7-1.5UFC371501
6MF2UFC3MF203
7MF6UFC3MF604
8MF9UFC3MF904
9MF13UFC3MFD04
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