IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 3) - Indonesia BPOM Medical Device Registration
IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 3) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303915979. 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.
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.
Risk Classification
Product Class
Kelas : 1
Manufacturer
TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.Country of Origin
China
Authorized Representative
PT. FAJAR SELARAS PARTNERSAR 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
IRENE Instrument Set for DIAMOND Hip system (Total Hip)
IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 1)
IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 2)
IRENE Instrument Set
IRENE Instrument Set For Screw Extraction
IRENE Instrument Set For 5.0mm Large Fragment Locking Plate System
IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 4)
IRENE Instrument Set For 3.5mm Small Fragment Locking Plate System
NAVIGATOR Intramedullary Nail System
NAVIGATOR Intramedullary Nail System
DELPHI II
CNS MEDICAL CO., LTD.
AnyPlusII Pedicle Screw System-6
GS MEDICAL CO., LTD.
AnyPlusII Pedicle Screw System-3
GS MEDICAL CO., LTD.
AnyPlusII Pedicle Screw System-5
GS MEDICAL CO., LTD.
AnyPlus II Pedicle Screw System-7
GS MEDICAL CO., LTD.
AnyPlusII Pedicle Screw System-4
GS MEDICAL CO., LTD.
IRENE Locking Plate System
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.
PYXIS 3D Titanium T-PLIF Cage (Sterile)
GS MEDICAL CO., LTD.
AnyPlusII Pedicle Screw System-1
GS MEDICAL CO., LTD.
AnyPlusII Pedicle Screw System-2
GS MEDICAL CO., LTD.

