GC CERVICAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FUJI II LC

FDA 510(k)

FDA Class 2 ·Dental

76 EMA LINING CEMENT

FDA 510(k)

FDA Class 2 ·Dental

SURFLEX F

FDA 510(k)

FDA Class 2 ·Dental

FUJI CAP II CAPSULE & APPLIER

FDA 510(k)

FDA Class 2 ·Dental

Columns, Glc

FDA classification

FDA Class 1 ·Columns, Glc

Gases, Glc

FDA classification

FDA Class 1 ·Gases, Glc

Monitor, U.V., Glc

FDA classification

FDA Class 1 ·Monitor, U.V., Glc

Coating, Liquid, Glc

FDA classification

FDA Class 1 ·Coating, Liquid, Glc

Column Supports, Glc

FDA classification

FDA Class 1 ·Column Supports, Glc

Gyn Partner s.r.o.

Importer

🇨🇿 Czechia

Cooling Gel

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Geocos B.V.·1 device

Revitex

Basic UDI-DI

EU MDR · Eu Md Class 2a ·S.A.R.L. MONTE-CARLO ESTHETICS·11 devices

Semiconductor Laser Treatment

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Counter Scientific Development (GZ) Limited·1 device

Vectorcardiograph

FDA classification

FDA Class 2 ·Vectorcardiograph

Catheter, Upper Urinary Tract

FDA classification

FDA Class 2 ·Catheter, Upper Urinary Tract

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

FDA classification

FDA Class 1 ·Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

Total Gym Europe B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer·1 Device

HD 1809159

Certificate

MDD Annex II (excluding section 4)·GHC Global Health Care GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

Elevate Encompass

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Total Gym Commercial LLC·1 device