BIOSILK Silk Non-Absorbable Suture - Indonesia BPOM Medical Device Registration
BIOSILK Silk Non-Absorbable Suture is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603816042. The device is manufactured by BIOSINTEX S.R.L. from Romania, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BIO AXION HEALTHINDO.
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
BIOSINTEX S.R.L.Country of Origin
Romania
Authorized Representative
PT. BIO AXION HEALTHINDOAR Address
Komplek Golden Plaza Blok G39-G42, Jl. RS Fatmawati, Kode Pos 12420 Kel. Gandaria Selatan, Kec. Cilandak, Kota Jakarta Selata, Prov. DKI Jakarta
Registration Date
Aug 11, 2023
Expiry Date
Jun 26, 2028
Product Type
Surgical Equipment
Natural nonabsorbable silk surgical suture.
Non Electromedic Sterile
DACRIL
BIOPRO Polypropylene Non-Absorbable Suture
MONOx Poliglecaprone Absorbable Suture
DACRIL Rapid
BIONIL MONOx
PDOx Polydioxanone Absorbable Suture
BIOSINTEX NYLON MONO Polyamide Non-Absorbable Suture
BIOSTER Polyester Non-Absorbable Suture
BICRIL RAPID Polyglycolid Acid Absorbable Suture
BICRIL Polyglycolid Acid Absorbable Suture
BIOPRO Polypropylene Non-Absorbable Suture
BIOSINTEX S.R.L.
MONOx Poliglecaprone Absorbable Suture
BIOSINTEX S.R.L.
AXIMED Chromic Catgut Surgical Suture
SHANXIAN RUNTE MEDICAL INSTRUMENTS CO., LTD.
AXIMED Plain Catgut Surgical Suture
SHANXIAN RUNTE MEDICAL INSTRUMENTS CO., LTD.
AXIMED Non Woven Fixation
HONY MEDICAL CO., LTD.
AXIMED Paper Tape
HONY MEDICAL CO., LTD.
AXIMED® Lancet
HUAIAN TIANDA MEDICAL INSTRUMENTS CO., LTD.
AXIMED Rectal Tube
JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO.,LTD
AXIMED Suction Catheter
WELL LEAD MEDICAL CO.,LTD
AXIMED Nasal Oxygen
XUYI CAREYOU MEDICAL PRODUCT CO., LTD.