Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Adiponectin（ADP） Assay Kit (Latex Enhanced Immunoturbidimetric Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

ATRUMATIC TISSUE FORCEPS DE BAKEY TITANIAM 240MM

Basic UDI-DI

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

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740014346·ARCHITECT Total T3 Manual Diluent

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740014322·ARCHITECT Total T3 Reagent Kit (100T)

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740014254·ARCHITECT Free T3 Calibrators

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740014308·ARCHITECT Total T3 Calibrators

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740105921·ARCHITECT Free T3 Reagent Kit (500T)

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740014261·ARCHITECT Free T3 Controls

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740014285·ARCHITECT Free T3 Reagent Kit (100T)

ARCHITECT

FDA UDI

ABBOTT IRELAND·00380740105945·ARCHITECT Total T3 Reagent Kit (500T)

MDP Company GmbH

Importer

🇦🇹 Austria·2 Manufacturers

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase

FDA classification

FDA Class 1 ·Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase

Hemodialyzer With Expanded Solute Removal Profile

FDA classification

FDA Class 2 ·Hemodialyzer With Expanded Solute Removal Profile

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Radioimmunoassay, Total Triiodothyronine

FDA classification

FDA Class 2 ·Radioimmunoassay, Total Triiodothyronine

Radioimmunoassay, Phenobarbital

FDA classification

FDA Class 2 ·Radioimmunoassay, Phenobarbital

ACEKARE

Authorized representative

🇫🇷 France·1 Manufacturer

CHIRASTAR KDT, s.r.o.

System producer

🇨🇿 Czechia