Papilloplex® HR-HPV DNA Kit - Indonesia BPOM Medical Device Registration
Papilloplex® HR-HPV DNA Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320372. The device is manufactured by GENEFIRST LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SEGMED DISTRIBUTION INDONESIA.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
GENEFIRST LIMITEDCountry of Origin
United Kingdom
Authorized Representative
PT. SEGMED DISTRIBUTION INDONESIAAR Address
SEGMED DISTRIBUSI INDONESIA
Registration Date
Dec 22, 2023
Expiry Date
Jul 15, 2026
Product Type
Tumor Antigen Immunologic Test System
Dna Detection for Human Papillomavirus
Invitro Diagnostics
Fluorobeads™ T Lymphocyte
ONE LAMBDA INC.
ONE LAMBDA PE-Conjugated Goat Anti-Human IgG
ONE LAMBDA INC.
Fluorobeads™ B Lymphocyte
ONE LAMBDA INC.
FlowPRA™ Negative Control
ONE LAMBDA INC
FlowPRA ™ Class I Positive Control
ONE LAMBDA INC.
LABScan 3D Verification Kit
LUMINEX CORPORATION
LABScreen ™ Negative Control
ONE LAMBDA INC.
LABScan 3D Calibration Kit
LUMINEX CORPORATION
Lyophilized Class I Complement
ONE LAMBDA INC.
Lyophilized Class II Complement
ONE LAMBDA INC.

