NIHON KOHDEN MEK-3DN Normal Hematology Control - Indonesia BPOM Medical Device Registration

NIHON KOHDEN MEK-3DN Normal Hematology Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208313248. The device is manufactured by R & D SYSTEM INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GANDASARI EKASATYA.

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BPOM Registered

Risk Class Kelas Resiko : B

NIHON KOHDEN MEK-3DN Normal Hematology Control

Analysis ID: AKL 20208313248

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

R & D SYSTEM INC.

Country of Origin

United States

Authorized Representative

PT. GANDASARI EKASATYA

AR Address

Jl. Raya HANKAM No.9A RT.007/002 Kel. Bambu Apus, Kec. Cipayung 13890

Registration Date

Dec 18, 2023

Expiry Date

May 30, 2026

Product Type

Hematological Reagents

Hematology quality control mixture.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Other Products from R & D SYSTEM INC.

Products from the same manufacturer (5 products)

NIHON KOHDEN MEK-5D Hematology Control for Five Part Differential

Kelas Resiko : B

NIHON KOHDEN MEK-5DN Hematology Control for Five Part Differential

Kelas Resiko : B

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Kelas Resiko : B

OPRHEE MYTH-3D

Kelas Resiko : B

NIHON KOHDEN MEK-3DL and MEK-3DH Hematology Control

Kelas Resiko : B

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Products with the same authorized representative (10 products)

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Kelas Resiko : B

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Kelas Resiko : B

NIHON KOHDEN Automated Hematology Analyzer MEK-1301 Celltac α and Accessories

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Kelas Resiko : B

CELLTAC G+ Automated Hematology Analyzer MEK-9200 and Accessories

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Kelas Resiko : B

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Kelas Resiko : A

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Kelas Resiko : B