Stimulator, Intracerebral/Subcortical, Implanted

FDA classification

FDA Class 3 ·Stimulator, Intracerebral/Subcortical, Implanted

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus and Fully Automatic AED Plus

BIP Medical CZ, s.r.o.

Importer

🇨🇿 Czechia

HD 2062692-1

Certificate

MDD Annex II (excluding section 4)·Nexmed Technology Co.,Ltd.·TÜV Rheinland LGA Products GmbH·6 Basic UDI-DIs

HD 2062682-1

Certificate

MDD Annex II (excluding section 4)·Nexmed Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U

BYO-TECH SAS

Authorized representative

🇫🇷 France·1 Manufacturer·11 Devices

Joint, Temporomandibular, Implant

FDA classification

FDA Class 3 ·Joint, Temporomandibular, Implant

ACTIPROTECT UC N95 RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD

ATRUMATIC TISSUE FORCEPS DE BAKEY TITANIAM 240MM

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Daddy D Pro·1 device

M.2022.MDR.1004

Certificate

MDR QA·BRP Sağlık Sanayi Ticaret A.Ş.·UDEM Adriatic d.o.o.

M.2022.MDR1003

Certificate

MDR QA·BRP Sağlık Sanayi Ticaret A.Ş.·UDEM Adriatic d.o.o.

Needle, Conduction, Anesthetic (W/Wo Introducer)

FDA classification

FDA Class 2 ·Needle, Conduction, Anesthetic (W/Wo Introducer)

Dropper, Ether

FDA classification

FDA Class 1 ·Dropper, Ether

BYT Associates/Consult Medical

Authorized representative

🇪🇸 Spain

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP,

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Teal Wand

FDA 510(k)

FDA Class 2 ·Microbiology