4,960 results · 37ms · Sources: EU EUDAMED, US FDA

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

Gemini Business Solutions GmbH

Authorized representative
🇩🇪 Germany·2 Manufacturers·2 Devices

Tehmed d.o.o.

Importer
🇭🇷 Croatia·4 Manufacturers

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) Assay.

MEDISYNER s.r.o.

Importer
🇨🇿 Czechia·5 Manufacturers

DHI GLOBAL EUROPE ΣΥΜΒΟΥΛΕΥΤΙΚΕΣ ΥΠΗΡΕΣΙΕΣ ΚΑΙ ΠΡΟΩΘΗΣΗ ΥΠΗΡΕΣΙΩΝ ΚΑΙ ΠΡΟΙΟΝΤΩΝ ΕΤΑΙΡΕΙΑ ΠΕΡΙΟΡΙΣΜΕΝΗΣ ΕΥΘΥΝΗΣ

Importer
1 Manufacturer

OMC NI MEDICAL LIMITED

Authorized representative
13 Manufacturers·18 Devices

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Medtronic B.V.

Authorized representative
🇳🇱 Netherlands·21 Manufacturers

Orthana GmbH

Importer
🇩🇪 Germany·12 Manufacturers

CA PRIMA 1:121

FDA registration
BIEN-AIR PORTUGAL, UNIPESSOAL LDA·1 product·🇵🇹 Portugal

CA PRIMA 1:121

FDA registration
BIEN-AIR DENTAL SA·1 product·🇨🇭 Switzerland

MediMark Europe Sarl.

Authorized representative
🇫🇷 France·35 Manufacturers·3394 Devices

Ortho Organizers GmbH

Importer
🇩🇪 Germany·34 Manufacturers

VYGON

Importer
🇫🇷 France·26 Manufacturers

Medtronic B.V.

Importer
🇳🇱 Netherlands·36 Manufacturers

Wellkang Ltd

Authorized representative
259 Manufacturers·3500 Devices

Emergo Europe B.V.

Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices

SUNGO Europe B.V.

Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices