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Sources: EU EUDAMED, US FDA
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Country: China
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HAINING XINHUA PAPER CUP FACTORY
FDA registration
HAINING XINHUA PAPER CUP FACTORY·1 product·🇨🇳 China
OrbusNeich Medical (Shenzhen) Co.,Ltd
Manufacturer
🇨🇳 China·1058 Basic UDI-DIs·1058 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Wondfo T-Cup Multi-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOEASY Multi-Drug Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOEASY Multi-Drug Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology