Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

Kahl Handelsvertretung

Authorized representative

🇩🇪 Germany·1 Manufacturer·1 Device

Kai Europe GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer·6 Devices

HZ 2066395-1

Certificate

MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH

HX 1034230-1

Certificate

IVDR QMS·nal von minden GmbH·TÜV Rheinland LGA Products GmbH

FF1-210 BALANCIER SANS CHARGES (BAL FF1-209)

Basic UDI-DI

EU MDD · Eu Md Class 1 ·ETABLISSEMENTS FRANCO ET FILS·1 device

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·14 devices

Pal Hygiene Products Limited

Importer

🇮🇪 Ireland·1 Manufacturer

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

TRİMPEKS İTHALAT İHRACAT TURİZM VE TİCARET A.Ş.

Importer

🇹🇷 Türkiye·1 Manufacturer

BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)

FDA 510(k)

FDA Class 2 ·General Hospital

MULTILASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nuvo Nano Portable Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

C-QUEST

FDA 510(k)

FDA Class 2 ·Radiology

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

iC-GPC Assay TM for use on the iC-SystemTM

FDA 510(k)

FDA Class 2 ·Microbiology

STERILE, POWDERFREE LATEX EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital