HELMER iUF118-GX Ultra Low Temperature Freezer - Indonesia BPOM Medical Device Registration
HELMER iUF118-GX Ultra Low Temperature Freezer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209520003. The device is manufactured by HELMER INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FRISMED HOSLAB 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
HELMER INCCountry of Origin
United States
Authorized Representative
FRISMED HOSLAB INDONESIAAR Address
Ruko Bidex Blok G No. 30-31 Jl. Pahlawan Seribu BSD City, 15321
Registration Date
Jan 03, 2025
Expiry Date
Dec 31, 2026
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Blood storage refrigerator and blood storage freezer.
Invitro Diagnostics
HELMER PC4200-PRO Platelet Incubator
HELMER PC2200-PRO Platelet Incubator
HELMER PC3200-PRO Platelet Incubator
HELMER PC3200h Incubator
HELMER PC2200h Incubator
HELMER PF96i Sharrer
HELMER HBF125-GX Plasma Freezer
HELMER iBF125-GX Plasma Freezer
HELMER HBF120-GX Plasma Freezer
HELMER iBF120-GX Plasma Freezer
HELMER PC2200-PRO Platelet Incubator
HELMER INC
CENTRON Separator ES315
CENTRON TECHNOLOGIES INC
CE-lMMUNDIAGNOSTIKA Anti-B B-6F9
CE-IMMUNDIAGNOSTIKA GMBH,
CE-lMMUNDIAGNOSTIKA Anti-D Incomplete
CE-IMMUNDIAGNOSTIKA GMBH,
FREEZmatic V2 and Accessories
WUHAN JINHONG BIOTECH DEVELOPMENT CO., LTD.
LMB Manual Plasma Extractor
LMB TECHNOLOGIE GMBH
DG Gel DC Scan Plus
DIAGNOSTIC GRIFOLS, S.A
HELMER PC3200h Incubator
HELMER INC
HELMER PC2200h Incubator
HELMER INC
GRIFOLS Anti-IgG
MEDION GRIFOLS DIAGNOSTICS AG

