ReBorn Essence Lumbar Fixation System (1) - Indonesia BPOM Medical Device Registration
ReBorn Essence Lumbar Fixation System (1) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302420052. The device is manufactured by BAUI BIOTECH CO., LTD. from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ARJAYA LANGGENG MEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BAUI BIOTECH CO., LTD.Country of Origin
Taiwan (China)
Authorized Representative
PT. ARJAYA LANGGENG MEDIKAAR Address
GRAHA SIMATUPANG TOWER 2C, LANTAI 4. JL. TB. SIMATUPANG KAV. 38 Kode Pos: 12540
Registration Date
Feb 21, 2024
Expiry Date
Jun 25, 2028
Product Type
Prosthetic Orthopedic Equipment
Pedicle screw spinal system
Non Electromedic Non Sterile
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ReBorn Essence Posterior Cervical Fixation System
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TRAUFIX Osteosynthesis Plate
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BAUI ReBorn Essence T-Lock Cervical Intervertebral Cage
BAUI BIOTECH CO., LTD.
ReBorn Essence Anterior Cervical Plate System
BAUI BIOTECH CO., LTD.
ReBorn Essence Lumbar Fixation System (3)
BAUI BIOTECH CO., LTD.
ReBorn Essence Nova Spinal Fixation System (2)
BAUI BIOTECH CO., LTD.

