5,215 results · 39ms · 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