Plexa ProMRI SD - Indonesia BPOM Medical Device Registration
Plexa ProMRI SD is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503913600. The device is manufactured by BIOTRONIK SE & CO., KG from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TRANSMEDIC INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
BIOTRONIK SE & CO., KGCountry of Origin
Germany
Authorized Representative
PT. TRANSMEDIC INDONESIAAR Address
Perkantoran Menara Era Unit G-01 & G-02 Jl. Senen Raya No 135-137, Kel. Senen Kec. Senen, Jakarta Pusat 10410
Registration Date
Jun 14, 2019
Expiry Date
Mar 31, 2024
Product Type
Prosthetic Cardiology Equipment
Pacemaker lead adaptor.
Non Electromedic Sterile
RENAMIC
SOLIA Implantable Lead
ENTICOS 4 D
ENTICOS 4 DR
Plexa ProMRI S DX
SELECTRA Slitter
Intica 7 VR-T
Sentus ProMRI OTW QP S-XX/49
INTICA 7 VR-T DX
INTICA 5 DR-T
SANYOU Spinal Rod System (Cervical) Implant
SHANGHAI SANYOU MEDICAL CO., LTD.
HEARTMATE 3 Left Ventricular Assist System (LVAS)
ABBOTT MEDICAL
SANYOU Spinal Rod System (Thoracolumbar) 6
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Cervical) Instrument
SHANGHAI SANYOU MEDICAL CO., LTD.
INGEVITY™+ Lead
BOSTON SCIENTIFIC PUERTO RICO LLC.
INGEVITY™ MRI Lead
BOSTON SCIENTIFIC PUERTO RICO LLC
RELIANCE 4-FRONT™ Active Fixation
BOSTON SCIENTIFIC PUERTO RICO LLC.
STIMULAN KIT
BIOCOMPOSITES LIMITED
STIMULAN RAPID CURE
BIOCOMPOSITES LIMITED
SANYOU Spinal Rod System (Thoracolumbar)
SHANGHAI SANYOU MEDICAL CO., LTD.