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TECNIS PureSee™ IOL with TECNIS Simplicity™ Delivery System - Indonesia BPOM Medical Device Registration

TECNIS PureSee™ IOL with TECNIS Simplicity™ Delivery System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31202320169. The device is manufactured by AMO GRONINGEN B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is JOHNSON AND JOHNSON INDONESIA TWO.

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BPOM Registered
Risk Class Kelas Resiko : D
TECNIS PureSee™ IOL with TECNIS Simplicity™ Delivery System
Analysis ID: AKL 31202320169

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

AMO GRONINGEN B.V.

Country of Origin

Netherlands

Authorized Representative

JOHNSON AND JOHNSON INDONESIA TWO

AR Address

K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950

Registration Date

Oct 04, 2023

Expiry Date

May 15, 2028

Product Type

Prosthetic Eye Equipment

Intraocular lens.

Non Electromedic Sterile

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