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PRECIZON Monofocal - Indonesia BPOM Medical Device Registration

PRECIZON Monofocal is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31202918122. The device is manufactured by OPHTEC B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. KHASANAH ALKESINDO.

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 : D
PRECIZON Monofocal
Analysis ID: AKL 31202918122

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

OPHTEC B.V.

Country of Origin

Netherlands

Authorized Representative

PT. KHASANAH ALKESINDO

AR Address

Jl. Prof. Dr. Soepomo SH, No.178 A Royal Palace B 39. RT. 001 RW. 015, Prov. DKI Jakarta, Kota Jakarta Selatan, Kec. Tebet, Kel. Menteng Dalam

Registration Date

Dec 04, 2023

Expiry Date

Apr 04, 2027

Product Type

Prosthetic Eye Equipment

Intraocular lens.

Non Electromedic Sterile

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