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EPIC X Diode Laser System - Indonesia BPOM Medical Device Registration

EPIC X Diode Laser System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603324515. The device is manufactured by BIOLASE, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FONDACO JAYATAMA.

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BPOM Registered
Risk Class Kelas Resiko : C
EPIC X Diode Laser System
Analysis ID: AKL 21603324515

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOLASE, INC.

Country of Origin

United States

Authorized Representative

PT. FONDACO JAYATAMA

AR Address

Agung Podomoro Land Tower, Podomoro City Lt. 27 T1, T2, T5 Jl. Letnan Jendral Siswondo Parman Kav. 28 Kel. Tanjung Duren Selatan, Kec. Grogol Petamburan, Jakarta Barat, DKI Jakarta

Registration Date

Jul 25, 2023

Expiry Date

Jan 19, 2028

Product Type

Surgical Equipment

Laser surgical instrument for use in general and plastic surgery and in dermatology.

Non Radiation Electromedics

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