OPTIMA Fold - Indonesia BPOM Medical Device Registration
OPTIMA Fold is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31202810481. The device is manufactured by EXCELLENT HI-CARE PRIVATE LIMITED from India, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. KHASANAH ALKESINDO.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
EXCELLENT HI-CARE PRIVATE LIMITEDCountry of Origin
India
Authorized Representative
PT. KHASANAH ALKESINDOAR Address
Jl. Prof. Dr. Soepomo SH, No.178A, Royal Palace B39, RT.001 RW.015, Menteng Dalam, Tebet
Registration Date
Jan 24, 2023
Expiry Date
Feb 25, 2026
Product Type
Prosthetic Eye Equipment
Intraocular lens.
Non Electromedic Sterile
Mac Edge Single Piece PMAA Aspheric 360° Square Edge Intraocular Lens
OPTIMA Clear
OPTIMA LENS - PMMA Intraocular Lens
OPTIMA LENS - PMMA Intraocular Lens
OPTIMA Vue Plus - Hydrophobic Acrylic Foldable Intraocular Lens (Preloaded)
Hydrophilic Acrylic Foldable Aspheric 360° Square Edge Intraocular Lens
OPTIMA LENS - PMMA Intraocular Lens
OPTIMA VUE - Hydrophobic Acrylic Foldable Intraocular Lens
OPTIMA VUE - Hydrophobic Acrylic Foldable Intraocular Lens
OPTIMA Vue Plus - Hydrophobic Acrylic Foldable Intraocular Lens (Preloaded)
PRECIZON GO
OPHTEC B.V
FOCUS 8/0 PGA
AUROLAB
FOCUS 10/0 Nylon
AUROLAB
ARTISAN Myopia
OPHTEC B.V.
ARTISAN Aphakia
OPHTEC B.V.
OPHTEC Enclavation Needle
OPHTEC B.V.
ARTISAN Toric
OPHTEC B.V.
ARTIFLEX Myopia
OPHTEC B.V.
ARTIFLEX Toric
OPHTEC B.V.
CATAGEL Plus Sodium Hyaluronate Ophthalmic Solution - 1.8%w/v
OPHTHALMIC TECHNOLOGY