Proquinorte S.A.

Importer

🇪🇸 Spain·2 Manufacturers

MAST DIAGNOSTIC

Importer

🇫🇷 France·3 Manufacturers

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Triolab AB

Importer

🇸🇪 Sweden·5 Manufacturers

GE Healthcare Austria GmbH & Co OG

Importer

🇦🇹 Austria·1 Manufacturer

GE Healthcare Austria GmbH & Co OG

Importer

🇦🇹 Austria

Shu Uemura Urban Moisture Hydro-Nourishing Conditioner

FDA registration

NARAYANSWARUP (UK) LIMITED·1 product·🇬🇧 United Kingdom

Franz Röseler oHG, Inh. Franz Uwe Röseler e.K.

Importer

🇩🇪 Germany

Triolab AS

Importer

🇳🇴 Norway·5 Manufacturers

1434-MDD-149/2021

Certificate

MDD Annex II Section 4·RFBio Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

TNP/MDR/0021/4830/2024

Certificate

MDR QMS·INVENTMED Sp. z o. o.·TUV NORD Polska Sp. z o.o

GCQ 004827 0002

Certificate

MDD Annex II (excluding section 4)·Guangzhou OO Medical Scientific Limited·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology

TNP/MDR/0007/4332/2023

Certificate

MDR QMS·Enbio Technology Sp. z o. o.·TUV NORD Polska Sp. z o.o

TNP/MDD/0279/4332/2019

Certificate

MDD Annex II (excluding section 4)·Enbio Technology Sp. z o. o.·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI

INTERTEAM podjetje za proizvodnjo in trgovino d.o.o. Kočevje, Mestni Log IV/3

Importer

🇸🇮 Slovenia

Avant Medical

Importer

🇳🇱 Netherlands·12 Manufacturers

MDR Regulator Sp. z o. o.

Authorized representative

🇵🇱 Poland·2 Manufacturers·3 Devices

IlabU Sp. z o. o.

System producer

🇵🇱 Poland

Triolab AS

Importer

🇩🇰 Denmark·11 Manufacturers