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AyoTes CLIA Based Progesterone Test Kit - Indonesia BPOM Medical Device Registration

AyoTes CLIA Based Progesterone Test Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421715. The device is manufactured by BEIJING HOTGEN BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : B
AyoTes CLIA Based Progesterone Test Kit
Analysis ID: AKL 20101421715

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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

Sep 02, 2024

Expiry Date

Sep 01, 2027

Product Type

Clinical Chemistry Test System

Progesterone test system (kit & cair)

Invitro Diagnostics

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Other Products from PT. HEALTHY FAMILY FOCUS
Products with the same authorized representative (10 products)

AYOTES CLIA based Pepsinogen I (PGI) Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B

AYOTES CLIA based Soluble Growth Stimulation Expressed Gene 2 Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : C

AYOTES CLIA based ฮฑ - Fetoprotein Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : C

AYOTES CLIA based Cytokeratin 19 Fragments Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : C

AyoTes CLIA based Cortisol Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B

AyoTes CLIA based Aldosteron Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B

AyoTes CLIA based 25-hydroxy-vitamin D (25-OH VD) Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B

AyoTes CLIA based Testosterone Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B

AyoTes CLIA based Myoglobin (MYO) Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B

AYOTES CLIA Based Creatine Kinase MB (CK-MB) Test Kit

BEIJING HOTGEN BIOTECH CO., LTD.

Kelas Resiko : B