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TRABECULAR METAL Acetabular Revision System (TMARS) Augments and Restrictors - Indonesia BPOM Medical Device Registration

TRABECULAR METAL Acetabular Revision System (TMARS) Augments and Restrictors is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302020821. The device is manufactured by ZIMMER TRABECULAR METAL TECHNOLOGY, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. KALMED SEJAHTERA INDONESIA.

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Risk Class Kelas Resiko : C
TRABECULAR METAL Acetabular Revision System (TMARS) Augments and Restrictors
Analysis ID: AKL 21302020821

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. KALMED SEJAHTERA INDONESIA

AR Address

JL.TAMAN MINI PINTU 2 NO. 2, RT. 006 RW. 004

Registration Date

Oct 29, 2024

Expiry Date

Dec 08, 2026

Product Type

Prosthetic Orthopedic Equipment

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Non Electromedic Sterile

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