FCI Scleral Buckling Implants - Indonesia BPOM Medical Device Registration
FCI Scleral Buckling Implants is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21202811344. The device is manufactured by FRANCE CHIRURGIE INSTRUMENTATION SAS ( FCI S.A.S. ) from France, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEGA MEDICAL ABADI.
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 : 2
Country of Origin
France
Authorized Representative
PT. MEGA MEDICAL ABADIAR Address
Komplek Fatmawati Mas Blok B5 Kav. 207-208, Jl. RS. Fatmawati No. 20, RT. 005 RW. 010
Registration Date
Nov 13, 2023
Expiry Date
Aug 24, 2026
Product Type
Prosthetic Eye Equipment
Absorbable implant (scleral buckling method).
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