ECHELON FLEX 45 Powered Endopath Stapler - Indonesia BPOM Medical Device Registration
ECHELON FLEX 45 Powered Endopath Stapler is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603020919. The device is manufactured by NYPRO HEALTHCARE BAJA INC from Mexico, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. JOHNSON & JOHNSON NEW ZEALAND.
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
NYPRO HEALTHCARE BAJA INCCountry of Origin
Mexico
Authorized Representative
PT. JOHNSON & JOHNSON NEW ZEALANDAR Address
K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A
Registration Date
Mar 09, 2020
Expiry Date
Sep 26, 2024
Product Type
Surgical Equipment
Implantable staple.
Non Electromedic Sterile
PDS PLUS Antibacterial (Polydioxanone) Suture
ETHICON INC.
ETHIBOND EXCEL Coated Polyester
ETHICON, INC.
PROLENE Polypropylene Suture
ETHICON, INC
STRATAFIX Spiral PGA-PCL Knotless Tissue Control Device (Bi-Directional)
SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.
STRATAFIX Spiral PDO Knotless Tissue Control Device (Bi-Directional)
SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.
DERMABOND* Propen Topical Skin Adhesive
ETHICON LLC.
CARTO VIZIGO BI-DIRECTIONAL GUIDING SHEATH
FREUDENBERG MEDICAL LLC.
DERMABOND PRINEO Skin Closure System
ETHICON LLC.
PROLENE Polypropylene Monofilament Non-Absorbable Suture
ETHICON INC.
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device
ETHICON INC.