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SONALLEVE MR-HIFU V2 ACHIEVA 1.5T - Indonesia BPOM Medical Device Registration

SONALLEVE MR-HIFU V2 ACHIEVA 1.5T is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21502420006. The device is manufactured by PROFOUND MEDICAL OY from Finland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TRANSMEDIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : C
SONALLEVE MR-HIFU V2 ACHIEVA 1.5T
Analysis ID: AKL 21502420006

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Finland

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137

Registration Date

Jan 19, 2024

Expiry Date

Nov 25, 2027

Product Type

Therapeutic Radiology Equipment

High Intensity Focused Ultrasound

Non Radiation Electromedics

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