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AyoTes CLIA Based Procalcitonin (PCT) Test Kit - Indonesia BPOM Medical Device Registration

AyoTes CLIA Based Procalcitonin (PCT) Test Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420132. 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 Procalcitonin (PCT) Test Kit
Analysis ID: AKL 20303420132

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, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Gambir, Kel. Petojo Selatan

Registration Date

Apr 18, 2024

Expiry Date

Apr 17, 2027

Product Type

Serological Reagents

Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.

Invitro Diagnostics

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