BIAXIS QS - Indonesia BPOM Medical Device Registration
BIAXIS QS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603411397. The device is manufactured by HLS HYPERTECH LASER SYSTEMS GMBH. from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. REGENESIS 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
HLS HYPERTECH LASER SYSTEMS GMBH.Country of Origin
Germany
Authorized Representative
PT. REGENESIS INDONESIAAR Address
Jl. Sultan Iskandar Muda No. 7A & B
Registration Date
Dec 23, 2022
Expiry Date
Dec 07, 2027
Product Type
Surgical Equipment
Laser surgical instrument for use in general and plastic surgery and in dermatology.
Non Radiation Electromedics
TERMOSALUD VMAT PRO
TERMOSALUD
ULTRACOL 200
ULTRA V CO., LTD.
PLASMA IQ Portable Micro Electrosurgery
BERGER & KRAFT MEDICAL SP. ZO.O
LaserMe
BERGER & KRAFT MEDICAL SP. ZO.O.
EpilME
BERGER & KRAFT MEDICAL SP. ZO.O
LIPODEFINE 1470
INTERMEDIC ARFRAN S.A
CRISTAL PRO
DELEO S.A.S
Rigeneracons tube/ devices
HUMAN BRAIN WAVE SRL
S-HEART (Double Arm) Absorbable Polydioxanone Suture
META BIOMED CO., LTD.
BIAXIS Medical Laser Technology Machine QS PICO
HLS HYPERTECH LASER SYSTEMS GMBH