品質檢驗證書

A.B. Dental 符合國際最高標準,並已獲得多個國家的醫療藥品監管局的核准:FDA〈美國〉、CE〈歐洲〉、俄羅斯聯邦、AMAR〈以色列〉、中國 NMPA、印度FDA、台灣FDA、澳洲 TGA、烏克蘭等。

ce (bsi)

EC Certificate - Full Quality Assurance System

View or Download

iso (bsi)

Quality Management System - ISO 13485:2016

View or Download

FDA

Food and Drug Administration Regulations

View or Download

israel

Amar, The Israeli Ministry of Health’s Medical Device Regulation Unit

View or Download

china

Medical Devices Regulations

View or Download

mexico

Medical Devices Regulations

View or Download

Canada

Medical Devices Regulations

View or Download

singapore

Medical Devices Regulations

View or Download

australia

Medical Devices Regulations

View or Download

india

Medical Devices Regulations

View or Download

panama

Medical Devices Regulations

View or Download

russia

Medical Devices Regulations

View or Download

taiwan

Medical Devices Regulations

View or Download

Malaysia

Medical Devices Regulations

View or Download

Penguin RFA

Penguin RFA (Aseptico) registration

View or Download