OTIS Plates and Screws for High Tibial Osteotomy and Femoral Osteotomy - Indonesia BPOM Medical Device Registration
OTIS Plates and Screws for High Tibial Osteotomy and Femoral Osteotomy is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302321009. The device is manufactured by S.B.M. SAS from France, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ENDO INDONESIA.
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
S.B.M. SASCountry of Origin
France
Authorized Representative
ENDO INDONESIAAR Address
Jl. Raya Menganti 14
Registration Date
Nov 22, 2023
Expiry Date
Jun 20, 2027
Product Type
Prosthetic Orthopedic Equipment
Single/multiple component metallic bone fixation appliances and accessories.
Non Electromedic Sterile
OTIS Implants for High Tibial Osteotomy
FIXIT Threaded Anchor System
MENIX DUO Meniscal suture system, 2 anchors
MENIX Instruments
MENIX Meniscal suture system,1 anchor
BIO 1 Implants for Bone Void Filling
BT LOOP Adjustable Fixation System for Ligament Reconstruction
ENDO Single Use Retrieval Net
ANREI MEDICAL (HANGZHOU) CO., LTD
ENDO Bite Block
ANREI MEDICAL (HANGZHOU) CO., LTD
POTENT Holmium Laser Therapeutic Apparatus
GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD.
ENDO Disposable Electrosurgical Pencils
JINHUA HUACHENG MEDICAL APPLIANCE CO., LTD
ROMSONS Intrasafe Intravenous Cannula
ROMSONS INTERNATIONAL
SEPLOU Percutaneous Nephrostomy Set with Pigtail Catheter
BONREE MEDICAL CO., LTD.
TONTARRA Flexible Ureterorenoscope
EMOS TECHNOLOGY GMBH
TONTARRA Flexible Cystoscope
EMOS TECHNOLOGY GMBH
ENDO Trauma Implants Instruments
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.
HUONS Automated Endoscope Reprocessor
HUONS MEDITECH CO., LTD