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DEVICE DETAILS

NAME OF DEVICEULTRAFORMER III
ESTABLISHMENT NAMEELOGIO ASIA PACIFIC SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB7557426-226700
BRAND NAMECLASSYS
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.
DEVICE INTENDED PURPOSEA 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 REGISTRATION25/02/2026 - 24/02/2031

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1ULTRAFORMER III (Main Body)3217-00025-601
2Hand-piece ASSYUFH000002
3L4-4.5UFC344501
4L7-3.0UFC373001
5L7-1.5UFC371501
6MF1UFC3MF103
7MF2UFC3MF203
8MF3UFC3MF304
9MF5UFC3MF504
10MF6UFC3MF604
11MF9UFC3MF904
12MF13UFC3MFD04
13LCD Assembly (Main Body)K555-10402-001
14Tocuh PanelK55-10402-001
15LCD Module (Hand-piece)K550-0220H-001
16FuseG650-25010-001
17Key switchG010-00001-001
18AC Power Cord5620-00001-001
19AC Inlet7438-00170-001
20RelayD500-00001-001
21System SMPSG210-06312-003
2212V SMPSG210-00512-001
23RF SMPSG210-10848-003
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