Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor

FDA registration

GUANGDONG BIOLIGHT MEDITECH CO., LTD·14 products·🇨🇳 China

Patient Monitor models iM50,iM80

FDA registration

EDAN INSTRUMENTS, INC.·14 products·🇨🇳 China

iM60, iM70 Patient monitor

FDA registration

EDAN INSTRUMENTS, INC.·14 products·🇨🇳 China

PM-2000XL Pro

FDA registration

ADVANCED INSTRUMENTATIONS, INC.·14 products·🇺🇸 United States

MEDIBLU MEDICAL, LLC

FDA registration

MEDIBLU MEDICAL, LLC·14 products·🇺🇸 United States

DRE Waveline EZ-Max V2 Monitor

FDA registration

DRE Med·14 products·🇺🇸 United States

Colli-Pee® UAS® FV-5040

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·1 device

Colli-Pee® UCM® FV-5020

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

Colli-Pee® FV-5020

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·5 devices

ORAgene

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·9 devices

ORAgene (Swab-based DNA & Dx Collection Device)

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

OMNIgene GUT

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·1 device

OMNIgene ORAL

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·2 devices

OG-AC1

Basic UDI-DI

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·1 device

ORAcollect (Swab based RNA Collection Device)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·1 device

ORAcollect (Swab based DNA & Dx Collection Device)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·3 devices

Waveline Touch+

FDA UDI

Avante·00815871021197·

1434-IVDD-254/2022

Certificate

IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

Immunofluorescence Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Guangzhou Decheng Biotechnology Co., Ltd.·1 device

β-HCG Assay kit CLIA

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device