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AFFACARE Ultrasonic Surgical System - Indonesia BPOM Medical Device Registration

AFFACARE Ultrasonic Surgical System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603325074. The device is manufactured by AFFACARE MEDICAL (BEIJING) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
AFFACARE Ultrasonic Surgical System
Analysis ID: AKL 21603325074

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Sep 21, 2023

Expiry Date

Feb 29, 2028

Product Type

Surgical Equipment

Electrosurgical cutting and coagulation device and accessories.

Non Radiation Electromedics

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