6,887 results · 55ms · Sources: EU EUDAMED, US FDA

Sealant, Pit And Fissure, And Conditioner

FDA classification
FDA Class 2 ·Sealant, Pit And Fissure, And Conditioner

KroniKare iThermo Thermal Scanner

Basic UDI-DI
EU MDR · Eu Md Class 2a ·KroniKare Pte Ltd·1 device

Vintens Digital Wound-Management System

Basic UDI-DI
EU MDR · Eu Md Class 2a ·KroniKare Pte Ltd·1 device

KroniKare Wound Scanner

Basic UDI-DI
EU MDR · Eu Md Class 2a ·KroniKare Pte Ltd·1 device

GENSUAPP

Basic UDI-DI
EU MDR · Eu Md Class 1 ·MiyaHealth Pte. Ltd.·1 device

Us2.v1

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Eko.ai Pte Ltd·1 device

H-MAN

Basic UDI-DI
EU MDR · Eu Md Class 2a ·ARTICARES PTE LTD·1 device

BioMind Diagnostic Support Software

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Hanalytics Pte Ltd·1 device

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification
FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Humidifier, Respiratory Gas, (Direct Patient Interface)

FDA classification
FDA Class 2 ·Humidifier, Respiratory Gas, (Direct Patient Interface)

Cushion, Earphone (For Audiometric Testing)

FDA classification
FDA Class 1 ·Cushion, Earphone (For Audiometric Testing)

Access PCT

FDA 510(k)
FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)
FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)
FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)
FDA Class 2 ·Microbiology

OTT GLOBAL MEDTECH SRL

Authorized representative
🇷🇴 Romania·1 Manufacturer

4-Fold STANAG-2040/3204 Stretcher

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Golden Season Pte Ltd·1 device

4-Fold STANAG 3204 Stretcher

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Golden Season Pte Ltd·1 device

4-Fold STANAG 2040 Stretcher

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Golden Season Pte Ltd·1 device

2-Fold STANAG 3204 Stretcher

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Golden Season Pte Ltd·1 device