GETINGE Assured Self-Contained Biological Indicator (EO) - Indonesia BPOM Medical Device Registration
GETINGE Assured Self-Contained Biological Indicator (EO) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20901320428. The device is manufactured by STERITEC PRODUCTS MFG. CO. INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INTERGASTRA NUSANTARA.
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
STERITEC PRODUCTS MFG. CO. INC.Country of Origin
United States
Authorized Representative
PT. INTERGASTRA NUSANTARAAR Address
Pangeran Jayakarta 24/34-35 Mangga Dua Selatan Sawah Besar- Jakarta Pusat
Registration Date
May 16, 2023
Expiry Date
Jan 01, 2026
Product Type
General and Individual Hospital Equipment Monitoring
Sterilization process indicator.
Non Electromedic Non Sterile
GETINGE Assured Smart Read Biological Indicator (Steam)
GETINGET Assured Self-Contained Biological Indicator (Steam)
GETINGE Assured Protein Test Instrument Surface
GETINGE Assured Multicritical Process Variable Indicator (EO)
GETINGE Assured Multicritical Process Variable Indicator (Dry Heat)
GETINGE Assured Self-Contained Biological Indicator (VH2O2)
GETINGE Assured Wash Monitor Ultrasonic
GETINGE Assured Wash Monitor
GETINGE Assured Bowie Dick Mini Pack 134 C
GETINGE Assured Bowie Dick Test Pack 121 C
ELMASONIC Med
ELMA SCHMIDBAEUR GMBH.
ELMASONIC Med
ELMA SCHMIDBAEUR GMBH.
ELMASONIC Med
ELMA SCHMIDBAEUR GMBH.
ELMASONIC Med
ELMA SCHMIDBAEUR GMBH.
ELMASONIC Med
ELMA SCHMIDBAEUR GMBH.
GETINGE Poladus
GETINGE IC PRODUCTION POLAND SP. Z.O.O
ARJO Liquids Flusher Rinse
ARJOHUNTLEIGH AB
Arjohuntleigh Tenor
ARJOHUNTLEIGH POLAND SP. Z.O.O.
ARJOHUNTLEIGH Primo Ferro Recumbent Bathing System
ARJOHUNTLEIGH POLAND SP. Z.O.O.
WIPAK Steriking ITSG Sterilization Tapes
WIPAK PACKAGING (CHANGSU) CO., LTD