ENZTEC Sigma HP Instrument - Indonesia BPOM Medical Device Registration
ENZTEC Sigma HP Instrument is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303320363. The device is manufactured by ENZTEC LIMITED from New Zealand, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is JOHNSON AND JOHNSON INDONESIA TWO.
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 : 1
Manufacturer
ENZTEC LIMITEDCountry of Origin
New Zealand
Authorized Representative
JOHNSON AND JOHNSON INDONESIA TWOAR Address
K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950
Registration Date
Apr 06, 2023
Expiry Date
Nov 03, 2027
Product Type
Surgical Orthopaedic Equipment
Orthopedic manual surgical instrument.
Non Electromedic Non Sterile
ECHELON 3000 60mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 60mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 60mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 45mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 45mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 45mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ATTUNE All Poly Tibia
DEPUY ORTHOPAEDICS, INC.
HARMONIC 700 Shears
NPA DE MEXICO S, DE R.L DE C.V.
CORAIL HIP SYSTEM - Corail Revision Femoral Stem
VIANT CHAUMONT SAS
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (Bi-Directional)
ETHICON, LLC.

