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ReBorn Essence Lumbar Fixation System (3) - Indonesia BPOM Medical Device Registration

ReBorn Essence Lumbar Fixation System (3) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302420053. 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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BPOM Registered
Risk Class Kelas Resiko : C
ReBorn Essence Lumbar Fixation System (3)
Analysis ID: AKL 21302420053

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Taiwan (China)

Authorized Representative

PT. ARJAYA LANGGENG MEDIKA

AR 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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