R-EVO SMART CR - Indonesia BPOM Medical Device Registration
R-EVO SMART CR is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21203020060. The device is manufactured by OPTIKON 2000 SPA from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. OPMIC PERKASA MANDIRI.
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
Manufacturer
OPTIKON 2000 SPACountry of Origin
Italy
Authorized Representative
PT. OPMIC PERKASA MANDIRIAR Address
Jl.Puri Kencana Blok K7-3D 3rd Fl Kembangan Jakarta 11610
Registration Date
Aug 08, 2024
Expiry Date
Jun 14, 2029
Product Type
Surgical Eye Equipment
Phacofragmentation system.
Non Radiation Electromedics
MOPTIM Optical Biometer
SHENZHEN CERTAINN TECHNOLOGY CO., LTD
GOOD AIR
Bien Air Surgery Ltd
DUCKWORTH & KENT Scissors Titanium Opthalmic Instrument
DUCKWORTH & KENT LTD.
DUCKWORTH & KENT Titanium Surgical Instruments
DUCKWORTH & KENT LTD.
R-Evolution CR
OPTIKON 2000 S.P.A.
PhysIOL's ISOPURE 123
PHYSIOL'S S.A
PhysIOL's MICROPURE 123
PHYSIOL'S S.A
R-Evolution
OPTIKON 2000 S.P.A.
OTOPRONT Echoscope
HAPPERSBERGER OTOPRONT GMBH
OTOPRONT Audiometer
HAPPERSBERGER OTOPRONT GMBH.

