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IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 4) - Indonesia BPOM Medical Device Registration

IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 4) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303916981. The device is manufactured by TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. FAJAR SELARAS PARTNERS.

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BPOM Registered
Risk Class Kelas Resiko : A
IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 4)
Analysis ID: AKL 11303916981

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

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

Mar 20, 2024

Expiry Date

May 29, 2028

Product Type

Surgical Orthopaedic Equipment

Orthopedic manual surgical instrument.

Non Electromedic Non Sterile

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