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ZYBIO Urea (UREA) Kit (Urease-GLDH Method) - Indonesia BPOM Medical Device Registration

ZYBIO Urea (UREA) Kit (Urease-GLDH Method) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324604. The device is manufactured by ZYBIO INC., from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ZYBIO MEDICAL INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
ZYBIO Urea (UREA) Kit (Urease-GLDH Method)
Analysis ID: AKL 20101324604

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ZYBIO INC.,

Country of Origin

China

Authorized Representative

PT. ZYBIO MEDICAL INDONESIA

AR Address

Satrio Tower Unit 8, Lantai 14 No. 5 Bok C4, Jl. Prof. Dr, Satrio No. 7, Kel. Setiabudi, Kec. Kuningan Timur, Kota Jakarta Selatan, Prov. DKI Jakarta

Registration Date

Dec 21, 2023

Expiry Date

Jan 30, 2028

Product Type

Clinical Chemistry Test System

Urea nitrogen test system (kit & cair)

Invitro Diagnostics

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