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SERENITY Splint Kit - Indonesia BPOM Medical Device Registration

SERENITY Splint Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11602910780. The device is manufactured by ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. SERENITY 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 : A
SERENITY Splint Kit
Analysis ID: AKL 11602910780

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. SERENITY INDONESIA

AR Address

Komplek Ruko Permata Kota Blok Q No. 10 Jl. Pangeran Tubagus Angke No.170 RT.010 RW . 01

Registration Date

Oct 20, 2023

Expiry Date

Feb 07, 2028

Product Type

Prosthetic Surgical Equipment

Noninflatable extremity splint.

Non Electromedic Non Sterile

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