Pure Global

ALLCHEK™ Syphilis Rapid Test Dipstick - (WB/S/P) - Indonesia BPOM Medical Device Registration

ALLCHEK™ Syphilis Rapid Test Dipstick - (WB/S/P) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321341. The device is manufactured by HANGZHOU ALLTEST BIOTECH, CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is SAMUDERA INTI MEDISINDO.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
ALLCHEK™ Syphilis Rapid Test Dipstick - (WB/S/P)
Analysis ID: AKL 20303321341

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

SAMUDERA INTI MEDISINDO

AR Address

SAMUDERA INTI MEDISINDO

Registration Date

Aug 18, 2023

Expiry Date

Jul 30, 2027

Product Type

Serological Reagents

Treponema pallidum treponemal test reagents.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from HANGZHOU ALLTEST BIOTECH, CO., LTD.
Products from the same manufacturer (10 products)

D.TEST Malaria P.f./P.v. Rapid Test Cassette

Kelas Resiko : B

D.TEST Cocaine (COC) Rapid Test Cassette

Kelas Resiko : B

D.TEST Morphine (MOP) Rapid Test Cassette

Kelas Resiko : B

D.TEST Benzodiazepines (BZO) Rapid Test Cassette

Kelas Resiko : B

D.TEST Methamphetamine (MET) Rapid Test Cassette

Kelas Resiko : B

D.TEST Marijuana (THC) Rapid Test Cassette

Kelas Resiko : B

D.TEST Amphetamine (AMP) Rapid Test Cassette

Kelas Resiko : B

D.TEST Syphilis Rapid Test Cassette

Kelas Resiko : C

D.TEST Multi-Drug Rapid Test 5 Parameter (AMP1000/MOP300/THC50/MET1000/BZO300)

Kelas Resiko : C

ALLCHEK™ HCV Rapid Test Cassette - (WB/S/P))

Kelas Resiko : D
Other Products from SAMUDERA INTI MEDISINDO
Products with the same authorized representative (10 products)

ALLCHEK™ HCV Rapid Test Cassette - (WB/S/P))

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : D

ALLCHEK™ Dengue Duo NS1 & IgG/IgM Rapid Test - (WB/S/P)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C

YASEE® Twist-off Lancet

TIANJIN HUAHONG TECHNOLOGY CO., LTD.

Kelas Resiko : A

YASEE® Lancing Device

TIANJIN HUAHONG TECHNOLOGY CO., LTD.

Kelas Resiko : A

ALLCHEK™ Multi-Drug 8 Drugs Rapid Test 1-Step Cup (MOP300/COC300/MET1000/BZO300/AMP1000/CAR1000/K250/THC50)- (Urine)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C

ALLCHEK Urinalysis Reagent 10 P Dipstick (GLU,BIL,KET,SG,BLO,pH,PRO,URO,NIT,LEU)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C

ALLCHEK Multi-Drug 3 Drugs Rapid Test Panel (AMP1000/MET1000/THC50)-(Urine)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C

ALLCHEK Dengue IgG/IgM Rapid Test Cassette - (WB/S/P)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C

ALLCHEK Dengue NS1 Rapid Test Cassette - (WB/S/P)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C

ALLCHEK™ Syphilis Rapid Test Cassette - (WB/S/P)

HANGZHOU ALLTEST BIOTECH, CO., LTD.

Kelas Resiko : C