APIS Pedicle Screw System - Indonesia BPOM Medical Device Registration
APIS Pedicle Screw System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302912542. The device is manufactured by TDM CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAJAR SELARAS PARTNERS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
TDM CO., LTD.Country of Origin
Korea
Authorized Representative
PT. FAJAR SELARAS PARTNERSAR Address
Komplek Rukan PTC Blok 8C No. 28-29 Pulogadung Tel. 021-46827776 Fax. 021-46827033
Registration Date
Feb 15, 2021
Expiry Date
Oct 31, 2025
Product Type
Prosthetic Orthopedic Equipment
Pedicle screw spinal system
Non Electromedic Non Sterile
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