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ACUFEX Handheld Instruments - Indonesia BPOM Medical Device Registration

ACUFEX Handheld Instruments is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801313305. The device is manufactured by SMITH & NEPHEW INC., ENDOSCOPY DIVISION from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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BPOM Registered
Risk Class Kelas Resiko : B
ACUFEX Handheld Instruments
Analysis ID: AKL 20801313305

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5

Registration Date

Mar 23, 2022

Expiry Date

Dec 31, 2024

Product Type

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories.

Non Electromedic Non Sterile

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