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IRENE Intramedullary Nail System (Titanium) - Indonesia BPOM Medical Device Registration

IRENE Intramedullary Nail System (Titanium) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302811340. 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.

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Risk Class Kelas Resiko : C
IRENE Intramedullary Nail System (Titanium)
Analysis ID: AKL 21302811340

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

Intramedullary fixation rod.

Non Electromedic Non Sterile

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