HENG JIE Intramedullary Nail, Titanium - Indonesia BPOM Medical Device Registration

HENG JIE Intramedullary Nail, Titanium is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302516172. The device is manufactured by CHANGZHOU HENGJIE MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BINA ARTHA SEMESTA.

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BPOM Registered

Risk Class Kelas Resiko : C

HENG JIE Intramedullary Nail, Titanium

Analysis ID: AKL 21302516172

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

CHANGZHOU HENGJIE MEDICAL DEVICES CO., LTD.

Country of Origin

China

Authorized Representative

PT. BINA ARTHA SEMESTA

AR Address

RUKO PERUMAHAN GREEN AREA KAV.C JL. GANDUL PLN

Registration Date

Sep 27, 2024

Expiry Date

Dec 02, 2026

Product Type

Prosthetic Orthopedic Equipment

Intramedullary fixation rod.

Non Electromedic Non Sterile

DJ Fang

MedTech Regulatory Expert

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Products with the same authorized representative (10 products)

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TST Instrument Set - C

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HENG JIE Metal Bone Plate, Titanium - B

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Kelas Resiko : C

HENG JIE Metal Bone Plate Stainless Steel

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Kelas Resiko : C

HENG JIE Metal Bone Screw Stainless Steel

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Kelas Resiko : C

HENGJIE Proximal Femoral Nail Instrument Set

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Kelas Resiko : A

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Kelas Resiko : A

HENGJIE EFN Femoral Reconstruction Nail Instrument Set

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Kelas Resiko : A