5,215 results
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39ms
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Sources: EU EUDAMED, US FDA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
Homocysteine (HCY) Kit (Enzymatic Cycling Method)、HCY Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPO2 AD CB,BCI DB9M,DB9F,2M
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828189828·SPO2 AD CB,BCI DB9M,DB9F,2M
BCI Lifts (2 mm & 3 mm)
FDA UDI
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008738512551·Bone Conduction Implant Surgical Tool
REUS,BCI SPO2 SNSR,3.3',LG CLAM
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828182379·REUS,BCI SPO2 SNSR,3.3',LG CLAM
HYCOGEL
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·MEDI J Co., Ltd·1 device
HYCOGEL
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·MEDI J Co., Ltd·1 device
iHealth (model: PO3)
FDA registration
GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD·1 product·🇻🇳 Vietnam
Smart Otoscope Ear, Nose&Throat HD Camera (Model: 70676-TY)
FDA registration
GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD·1 product·🇻🇳 Vietnam
iHealth (model: KN-550BT)
FDA registration
GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD·1 product·🇻🇳 Vietnam
Curaplex
FDA UDI
BOUND TREE MEDICAL, LLC·00810094575953·Curaplex Pediatric BVM with Filterline Kit
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Homocysteine (Hcy) Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Homocysteine (Hcy) Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
FDA 510(k)
FDA Class 2
·Microbiology
Albumin, 12 x 20 mL, REF ALBU-0250-NA
FDA registration
VitalScientific·4 products·🇫🇷 France