资质认证与法规合规

已获认证

• FD FDA US market Cleared device listings; zero FDA observations since 2018, FDA fly check April 2024
• CE CE / EU MDR European Union MDR-compliant CE marking (NB 0123 / 0598)
• NM NMPA China market Registered devices; NMPA fly check
• IS ISO 13485 Quality management Medical device QMS
• IS ISO 14001 Environmental management Environmental QMS
• IS ISO 45001 Occupational health & safety OH&S management
• MD MDSAP Medical Device Single Audit Program Covers US, Canada, Brazil, Japan, Australia
• HE Health Canada (MDL) Canada market Medical device licences
• PM PMDA Japan market Registration pathway
• TG TGA Australia market ARTG entry via MDSAP
• UK UKCA United Kingdom UK conformity assessment
• IN INMETRO / ANVISA Brazil market Product certification & registration
• BS BSCI Social compliance Audited supply chain
• SM SMETA Social compliance Sedex members ethical audit
• CA CA65 California Prop 65 Chemical exposure compliance
• RO RoHS Hazardous substances Restriction compliance
• RE REACH Chemical safety EU chemical regulation
• RE RED Radio equipment EU Radio Equipment Directive
• FC FCC Radio frequency US RF compliance
• BL Bluetooth SIG Connectivity Bluetooth SIG member
• CF CFS Free sale certificate Export documentation

认证	适用范围	对您的意义
FDA	US market	Cleared device listings; zero FDA observations since 2018, FDA fly check April 2024
CE / EU MDR	European Union	MDR-compliant CE marking (NB 0123 / 0598)
NMPA	China market	Registered devices; NMPA fly check
ISO 13485	Quality management	Medical device QMS
ISO 14001	Environmental management	Environmental QMS
ISO 45001	Occupational health & safety	OH&S management
MDSAP	Medical Device Single Audit Program	Covers US, Canada, Brazil, Japan, Australia
Health Canada (MDL)	Canada market	Medical device licences
PMDA	Japan market	Registration pathway
TGA	Australia market	ARTG entry via MDSAP
UKCA	United Kingdom	UK conformity assessment
INMETRO / ANVISA	Brazil market	Product certification & registration
BSCI	Social compliance	Audited supply chain
SMETA	Social compliance	Sedex members ethical audit
CA65	California Prop 65	Chemical exposure compliance
RoHS	Hazardous substances	Restriction compliance
REACH	Chemical safety	EU chemical regulation
RED	Radio equipment	EU Radio Equipment Directive
FCC	Radio frequency	US RF compliance
Bluetooth SIG	Connectivity	Bluetooth SIG member
CFS	Free sale certificate	Export documentation

ISO 13485 质量体系

我们的质量体系遵循 ISO 13485。落到实操层面，它规范设计控制、供应商管理、生产可追溯性、不合格品处置与上市后监督——也正是公告机构或大型零售客户会审核的那批记录。

设计奖项

产品曾获得 8 项国际设计大奖，包括 Red Dot Product Design Award（2019 & 2023） 与 iF Product Design Award（2019, 2021, 2022 & 2023）。这是工业设计类奖项，不等同于法规批准——我们特意分列，不做混淆。

可交付文件

• 证书副本与认证范围说明。
• 认可实验室出具的检测报告。
• 符合性声明，以及适用时的 FDA 清关编号。
• 供您自行申报使用的技术文件摘录。