EU → North America Device Access

Medical device manufacturers in Greece and the U.S. market

45 manufacturers registered in Greece with at least 5 devices declared in the European database. Of these, 26 were not found in the U.S. FDA establishment register, 2 were matched, and 0 have a similar name that needs checking.

Against the Canadian register, 27 of them were not found, 0 hold a Health Canada licence, and 1 need checking.

ManufacturerDevices FDAHealth Canada
ADCO ORTHOPAEDICS LTD1 379Not found in the FDA registerNot found in the Canadian register
DMP Dental Industry S.A.1 054Registered with FDASimilar name found — unverified
ΑΝΑΤΟΜΙΚ ΧΕΛΠ ΑΝΩΝΥΜΗ ΕΤΑΙΡΙΑ ΕΜΠΟΡΙΑΣ ΚΑΙ ΚΑΤΑΣ724Name not comparable—
BOURNAS MEDICALS687Not found in the FDA registerNot found in the Canadian register
ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε.469Name not comparable—
Α. ΣΑΛΕΜΗΣ & ΣΙΑ ΕΕ - MEDICAL BRACE447Not found in the FDA registerNot found in the Canadian register
Medicon Hellas SA415Registered with FDANot found in the Canadian register
SIDAPHARM Private Company235Not found in the FDA registerNot found in the Canadian register
Biotechnological Applications Ltd209Not found in the FDA registerNot found in the Canadian register
ELECTROCHEM SILICONES LTD / ELECTROCHEM SILICONE169Not found in the FDA registerNot found in the Canadian register
ΜΟΝΑΔΑ ΒΙΟΜΗΧΑΝΙΚΩΝ ΙΑΤΡΙΚΩΝ ΑΕΡΙΩΝ ΚΡΗΤΗΣ (ΜΟΒΙ162Name not comparable—
ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E.152Not found in the FDA registerNot found in the Canadian register
ΧΡΙΣΤΟΦΟΡΟΣ ΚΥΦΙΔΗΣ ΚΑΙ ΣΙΑ Ε.Ε.120Name not comparable—
ΑΝΤΙΓΟΝΗ ΠΕΤΡΟΠΟΥΛΟΥ ΚΑΙ ΣΙΑ ΟΕ105Name not comparable—
MEDIFORM S.A.99Not found in the FDA registerNot found in the Canadian register
GEROLYMATOS INTERNATIONAL COMMERCIAL AND INDUSTR93Not found in the FDA registerNot found in the Canadian register
Mega Disposables S.A.83Not found in the FDA registerNot found in the Canadian register
G. PAPANIKOLAOU & CO. LP - Bioprepare82Not found in the FDA registerNot found in the Canadian register
IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORI78Not found in the FDA registerNot found in the Canadian register
SEPTONA ΑΝΩΝΥΜΟΣ ΒΙΟΜΗΧΑΝΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕ62Not found in the FDA registerNot found in the Canadian register
Μ.BIRLI - A.TSITOURAS O.E.61Not found in the FDA registerNot found in the Canadian register
ΟΡΘΟΔΥΝΑΜΙΚΗ ΑΝΩΝΥΜΟΣ ΒΙΟΤΕΧΝΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤ58Name not comparable—
ΜΠΙΝΗΣ ΑΝΩΝΥΜΟΣ ΕΙΣΑΓΩΓΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ54Name not comparable—
ΛΑΜΕΝΤ ΙΚΕ42Name not comparable—
ΜΟΝΟΠΡΟΣΩΠΗ ΑΝΩΝΥΜΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΙΑ36Name not comparable—
ΑΤΟΜΙΚΗ ΦΡΟΝΤΙΔΑ ΑΝΩΝΥΜΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤ31Name not comparable—
BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓ30Not found in the FDA registerNot found in the Canadian register
DYONMED SA29Not found in the FDA registerNot found in the Canadian register
ALPLA PHARMA GREECE Single Member S.Α.28Not found in the FDA registerNot found in the Canadian register
Han ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΚΑΤΑΣΚΕΥΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΑΝΑ23Not found in the FDA registerNot found in the Canadian register
G. SAMARAS S.A. MEDICAL GAS SYSTEMS17Not found in the FDA registerNot found in the Canadian register
ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ16Name not comparable—
THINKTANK LP15Not found in the FDA registerNot found in the Canadian register
DOCTUM PHARMACEUTICAL SA K.GIOKARIS & Co14Not found in the FDA registerNot found in the Canadian register
ΒΙΟΣΕΡ Α.Ε. ΒΙΟΜΗΧΑΝΙΑ ΠΑΡΕΝΤΕΡΙΚΩΝ ΔΙΑΛΥΜΑΤΩΝ14Name not comparable—
ΠΡΟΜΗΦΑΡ Ο.Ε.13Name not comparable—
ΣΥΝΔΕΣΜΟΣ ΑΝΩΝΥΜΗ ΕΙΣΑΓΩΓΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕ13Name not comparable—
ΠΑΠΠΑΣ Ν. & ΣΙΑ ΟΕ9Name not comparable—
ENDLESS EC - EvROCHARTIKI MONOPROSOPI AEVE8Not found in the FDA registerNot found in the Canadian register
iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙ7Not found in the FDA registerNot found in the Canadian register
STERGIOULAS VASILEIOS & Co L.P.7Not found in the FDA registerNot found in the Canadian register
ΣΤΡΩΜΑΤΟΠΟΙΙΑ ΑΘΗΝΩΝ ΕΠΕ7Name not comparable—
ΚΟΥΤΡΗΣ ΕΥΑΓΓΕΛΟΣ ΙΓΝΑΤΙΟΣ6Name not comparable—
THERMOGRAFICA HELLAS ΕΠΕ5Not found in the FDA registerNot found in the Canadian register
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATOR5Not found in the FDA registerNot found in the Canadian register

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