AyoTes HbA1c Control Material - Indonesia BPOM Medical Device Registration

AyoTes HbA1c Control Material is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320210. The device is manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD, CHINA from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.

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BPOM Registered

Risk Class Kelas Resiko : B

AyoTes HbA1c Control Material

Analysis ID: AKL 20207320210

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD, CHINA

Country of Origin

China

Authorized Representative

PT. HEALTHY FAMILY FOCUS

AR Address

Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9

Registration Date

Jan 25, 2023

Expiry Date

Jan 16, 2026

Product Type

Haematology Package and Kit

Glycosylated hemoglobin assay.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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