200234QS/NB

Certificate

MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·Gore Viatorr TIPS

Eureka

FDA UDI

Terarecon Inc.·B2208430011·Eureka AI Results Explorer (aka Northstar AI Re...

Medline International B.V.

Importer

🇳🇱 Netherlands·4 Manufacturers

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH LITHOTRIPTER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

FKG SWISS ENDO IBERIA,S.L.

Importer

🇪🇸 Spain

MODELLING LIQUID

Basic UDI-DI

EU MDR · Eu Md Class 1 ·HUZUR DENTAL TIBBİ ÜRÜNLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ·2 devices

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Test, Sorbent, Fta-Abs

FDA classification

FDA Class 2 ·Test, Sorbent, Fta-Abs

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Antiserum, Digoxin

FDA classification

FDA Class 2 ·Antiserum, Digoxin

Nadh Oxidation/Nad Reduction, Alt/Sgpt

FDA classification

FDA Class 1 ·Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pure EP - Catheter Input Module

FDA UDI

BIOSIG TECHNOLOGIES, INC.·00856750007048·The Catheter Input Module - IC2 J-Box Bipolar C...

Pure EP - Catheter Input Module

FDA UDI

BIOSIG TECHNOLOGIES, INC.·00856750007031·The Catheter Input Module - IC1 J-Box Unipolar/...

Pure EP - ECG Cable

FDA UDI

BIOSIG TECHNOLOGIES, INC.·00856750007055·The ECG Cable is an accessory to the PURE EP™ S...

Piccolo General Chemistry 6

FDA UDI

ABAXIS, INC.·EABA40000061·The Piccolo® General Chemistry 6 , used with th...

Piccolo Hepatic Function Panel

FDA UDI

ABAXIS, INC.·EABA40000261·The Piccolo® Hepatic Function Panel, used with ...

Piccolo Lipid Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000301·The Piccolo® Lipid Panel Plus, used with the Pi...