OPHICLEAN - Indonesia BPOM Medical Device Registration

OPHICLEAN is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20903023944. The device is manufactured by HUONS MEDITECH CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ELO KARSA UTAMA.

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BPOM Registered

Risk Class Kelas Resiko : B

OPHICLEAN

Analysis ID: AKL 20903023944

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

HUONS MEDITECH CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. ELO KARSA UTAMA

AR Address

Jl. Raya Kebayoran Lama No. 34-E, Grogol Selatan, Kebayoran Lama.

Registration Date

Aug 11, 2022

Expiry Date

Feb 24, 2024

Product Type

General Hospital Equipment and Other Individuals

Liquid chemical sterilants/high level disinfectants.

Non Electromedic Non Sterile

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Products from the same manufacturer (2 products)

HUONS Electromechanical Lithotriptor

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Kelas Resiko : B

YCHD Disposable Vacuum Blood Collection Tube EDTA K3

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Kelas Resiko : B

YCHD Disposable Vacuum Blood Collection Tube Clot Activator

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Kelas Resiko : B

YCHD Disposable Vacuum Blood Collection Tube EDTA K2

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Kelas Resiko : B

THERMO SCIENTIFIC Finnpipette F3 Fixed

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Kelas Resiko : A

THERMO SCIENTIFIC Finnpipette F3 Adjustable

THERMO FISHER SCIENTIFIC OY.

Kelas Resiko : A

THERMO SCIENTIFIC S1 Pipet Filler

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Kelas Resiko : A

THERMO SCIENTIFIC Finnpipette F1 Adjustable

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Kelas Resiko : A