GKE STERI RECORD Mini-Bio-Plus Self Contained Biological Indicators (H2O2) - Indonesia BPOM Medical Device Registration
GKE STERI RECORD Mini-Bio-Plus Self Contained Biological Indicators (H2O2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20901514124. The device is manufactured by GKE-GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is EN. LIMA DISPO SELARAS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
GKE-GMBHCountry of Origin
Germany
Authorized Representative
EN. LIMA DISPO SELARASAR Address
Jl. Pulo Sirih Barat Blok M/15, Jaka Setia, Bekasi 17147
Registration Date
Jul 12, 2023
Expiry Date
Dec 31, 2024
Product Type
General and Individual Hospital Equipment Monitoring
Sterilization process indicator.
Non Electromedic Non Sterile
GKE STERI-RECORD Double Self Adhesive 3 Line Label with EO Indicator
MESA GERMANY GMBH.
OPTIMUM Sterilization Packaging Non Woven Wraps
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OPTIMUM Sterilization Packaging Roll (GUSSETED)
JIANGSU PAKION MEDICAL MATERIAL CO., LTD
OPTIMUM Sterilization Plasma Tyvek Reel
JIANGSU PAKION MEDICAL MATERIAL CO., LTD
FULCARE Rapid Readout Biological Indicator for Plasma
CHENGDU FULCARE TRADING CO., LTD
FULCARE Rapid Readout Biological Indicator for Steam
CHENGDU FULCARE TRADING CO., LTD
DECONEX Prozyme Active
BORER CHEMIE AG.
PHARMA TRACH Heat- and Moisture Exchanger for Tracheostomized Patients
PHARMA SYSTEMS.
DECONEX 64 Neutradry
BORER CHEMIE AG.
DECONEX Foam Active
BORER CHEMIE AG.