7,973 results · 45ms · Sources: EU EUDAMED, US FDA

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DCS Innovative Diagnostik-Systeme Dr. Christian Sartori GmbH & Co. KG

Importer
🇩🇪 Germany·1 Manufacturer

Farmator spółka z ograniczona odpowiedzialnością

Importer
🇵🇱 Poland·1 Manufacturer

Farmabol spółka z ograniczoną odpowiedzialnością

Importer
🇵🇱 Poland·1 Manufacturer

Axon Lab AG

Authorized representative
🇦🇹 Austria·1 Manufacturer·1 Device

UAB "V&D group"

Authorized representative
🇱🇹 Lithuania·1 Manufacturer

UAB Herbion Group

Authorized representative
🇱🇹 Lithuania·1 Manufacturer

Regen Lab France

Authorized representative
🇫🇷 France·1 Manufacturer·41 Devices

SnorBan DK ApS

Importer
🇩🇰 Denmark·1 Manufacturer

Biolife Italiana srl

Importer
🇮🇹 Italy·4 Manufacturers

VISION RX LAB EUROPE

Importer
🇫🇷 France·1 Manufacturer

Y. Sung Handelsvertretung

Authorized representative
🇩🇪 Germany·80 Manufacturers

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Hettich Labinstrument

Importer
🇩🇰 Denmark·3 Manufacturers

HD601425650001

Certificate
MDD Annex II (excluding section 4)·Suzhou Armocon Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

US19/819943643

Certificate
MDD Annex II (excluding section 4)·Parkell Inc.·SGS Belgium NV·55 Basic UDI-DIs

Certificate
MDR Technical Documentation·UAB "Prodenta"·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-MDR-017/2024

Certificate
MDR QMS·UAB "Prodenta"·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

1434-MDR-018/2024

Certificate
MDR Technical Documentation·UAB "Prodenta"·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

HZ 1550682-1

Certificate
MDR QMS·Oxipit, UAB·TÜV Rheinland LGA Products GmbH