DIGORA OPTIME (OR DIGORA ONTIME)

FDA 510(k)

FDA Class 2 ·Dental

BonAlive Granules

FDA 510(k)

FDA Class 2 ·Orthopedic

HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology

DELTA 16

FDA 510(k)

FDA Class 2 ·Radiology

THERMOFX MESH

FDA 510(k)

FDA Class 2 ·Dental

FBI Medizintechnik GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

FI-LOG

Importer

🇫🇷 France

Vitacam V1

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Evondos Oy·1 device

SURGICAL PLETH INDEX LICENSE

Basic UDI-DI

EU MDD · Eu Md Class 2b ·GE Healthcare Finland Oy·1 device

MyNursie

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Nursie Health Oy·1 device

DiagMMR

Basic UDI-DI

EU IVDD · Eu Ivd General ·Lynsight Ltd ·1 device

Xpert® Nasal Sample Collection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Cepheid·1 device

efi Sports Medicine (GmbH & Co.) KG

Importer

🇩🇪 Germany

Rongeur, Cystoscopic

FDA classification

FDA Class 2 ·Rongeur, Cystoscopic

Cooler, Esophageal And Gastric

FDA classification

FDA Class 3 ·Cooler, Esophageal And Gastric

Total Spinal-Fluid, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Total Spinal-Fluid, Antigen, Antiserum, Control

PureMDR GmbH

Authorized representative

🇩🇪 Germany·9 Manufacturers·21 Devices

Co-Test Finland Oy

Importer

🇫🇮 Finland·4 Manufacturers