ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

FDA 510(k)

FDA Class 2 ·Immunology

Orthopantomograph™ OP 3D LX

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED CHLAMYSET ANTIGEN

FDA 510(k)

FDA Class 1 ·Microbiology

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

JFA Medical Wound Closure Strips 3mmx75mm, 5 strips per pouch - single pouch

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·1 device

FI-LOG

Importer

🇫🇷 France

0068/QPZ-DM/172-2020

Certificate

MDD Annex V·JMI SYRINGES & MEDICAL DEVICES LTD.·MTIC InterCert S.r.l.·34 Basic UDI-DIs

efi Sports Medicine (GmbH & Co.) KG

Importer

🇩🇪 Germany

Adaptor, Bulbs, Miscellaneous, For Endoscope

FDA classification

FDA Class 1 ·Adaptor, Bulbs, Miscellaneous, For Endoscope

System, Alarm, Electrosurgical

FDA classification

FDA Class 2 ·System, Alarm, Electrosurgical

Total Spinal-Fluid, Antigen, Antiserum, Control

FDA classification

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

Co-Test Finland Oy

Importer

🇫🇮 Finland·4 Manufacturers

fi medikal ltd.sti

Authorized representative

🇹🇷 Türkiye

Agfa NV

Importer

🇧🇪 Belgium·8 Manufacturers