CRYO PENGUIN ™ - Indonesia BPOM Medical Device Registration
CRYO PENGUIN ™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603129920. The device is manufactured by CRYO SCIENCE SP. SO.O. from Poland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. HARLISA TRUE GRACE.
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
CRYO SCIENCE SP. SO.O.Country of Origin
Poland
Authorized Representative
PT. HARLISA TRUE GRACEAR Address
Perum Sedati Permai Jl. Sriti HH-15
Registration Date
Dec 29, 2021
Expiry Date
Oct 28, 2024
Product Type
Surgical Equipment
Cryosurgical unit and accessories.
Non Radiation Electromedics
FISIOLINE Radiofrequency Instrument for Diathermy Therapy
FISIOLINE S.R.L.
UNICARE Fetal / Maternal Monitor
SHENZHEN UNICARE ELECTRONIC CO., LTD
EXOATLET II Powered Lower Extremity Exoskeleton
COSMO ROBOTICS CO., LTD.
AYSAM Mitral and Aortic Valve Instrument Set
AYSAM ORTOPEDI VE TIBBI ALETLERI SAN. VE TIC. LTD. STI.
FISIOLINE Lumix CW
FISIOLINE S.R.L.
Electrocardiograph OPUS 1
STRING POLSKA SP. Z O.O.
REMFAT Extracorporeal Shock Wave Therapy, ESWT
K1MED CO., LTD
STERNMED Digital Color Doppler Ultrasound System
STERNMED GMBH
RMS Electrocardiographs Holter
RECORDERS & MEDICARE SYSTEMS PVT. LTD.
SUPERSTAR CPAP System
NANJING SUPERSTAR MEDICAL EQUIPMENT CO., LTD.

