OPHTEIS ORGANIC 1.6 - Indonesia BPOM Medical Device Registration
OPHTEIS ORGANIC 1.6 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31203812539. The device is manufactured by RAYNER INTRAOCULAR LENSES LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is ENSEVAL PUTERA MEGATRADING TBK.
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.
OPHTEIS BIO 1.6
Risk Classification
Product Class
Kelas : 3
Manufacturer
RAYNER INTRAOCULAR LENSES LIMITEDCountry of Origin
United Kingdom
Authorized Representative
ENSEVAL PUTERA MEGATRADING TBKAR Address
Jalan Pulo Lentut No.10 Kawasan Industri Pulogadung, Jakarta Timur
Registration Date
Dec 08, 2022
Expiry Date
Sep 06, 2025
Product Type
Surgical Eye Equipment
Intraocular fluid.
Non Electromedic Sterile
RAYONE Aspheric
RAYONE Trifocal
RAYONE Hydrophobic Aspheric
RAYONE Toric
SULCOFLEX TRIFOCAL
RAYONE EMV
OPHTEIS ORGANIC 1.8%
SUPERFLEX Aspheric System Pack
C-FLEX System Pack
T-FLEX Aspheric
RENASYS GO Negative Pressure Wound Therapy
SMITH & NEPHEW INC. ENDOSCOPY DIVISION.
RENASYS Touch Canister with Solidifier
HARMAC MEDICAL PRODUCTS, INC.
IODOSORB Powder
PERSTORP SPECIALITY CHEMICALS AB.
RENASYS Touch Canister
VIANT COSTA RICA., SA
OPSITE Post-Op
SMITH & NEPHEW MEDICAL (SUZHOU) LIMITED
SMITH & NEPHEW Opsite
SMITH & NEPHEW MEDICAL (SUZHOU) LIMITED
ELECTOFIX
SHANGHAI ISO MEDICAL PRODUCTS CO., LTD.
NAVITAE
NOVAX PHARMA SARL.
VISIONLUX PLUS eye drops
ITALDEVICE S.R.L.

