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SOFWAVE Systems - Indonesia BPOM Medical Device Registration

SOFWAVE Systems is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603123549. The device is manufactured by SOFWAVE MEDICAL LTD from Israel, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. REGENESIS INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
SOFWAVE Systems
Analysis ID: AKL 21603123549

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Israel

Authorized Representative

PT. REGENESIS INDONESIA

AR Address

Jalan Sultan Iskandar Muda No. 7 A dan B, Kebayoran lama Selatan, Kebayoran Lama, Jakarta Selatan

Registration Date

Jul 12, 2024

Expiry Date

Oct 14, 2025

Product Type

Surgical Equipment

Focused ultrasound stimulator system for aesthetic use

Non Radiation Electromedics

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