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IRENE Knee Prosthesis - Indonesia BPOM Medical Device Registration

IRENE Knee Prosthesis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302613074. The device is manufactured by TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAJAR SELARAS PARTNERS.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
IRENE Knee Prosthesis
Analysis ID: AKL 21302613074

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. FAJAR SELARAS PARTNERS

AR Address

Komplek Rukan PTC Blok 8C No. 28-29 Pulogadung Tel. 021-46827776 Fax. 021-46827033

Registration Date

Feb 17, 2024

Expiry Date

May 29, 2028

Product Type

Prosthetic Orthopedic Equipment

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Non Electromedic Sterile

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