EVS 3643, EVS 3643G

FDA 510(k)

FDA Class 2 ·Radiology

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

FDA 510(k)

FDA Class 2 ·Radiology

EXTRON 3; EXTRON 5; EXTRON 7

FDA 510(k)

FDA Class 2 ·Radiology

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

FDA 510(k)

FDA Class 2 ·Radiology

EXPD 4357; EXPD 4357P

FDA 510(k)

FDA Class 2 ·Radiology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)

FDA 510(k)

FDA Class 2 ·Radiology

Flat Panel Digital X-ray Detector

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DRTECH Corporation·15 devices

Flat-Panel Digital X-ray Detector

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DRTECH Corporation·4 devices

Digital Mammography system

Basic UDI-DI

EU MDD · Eu Md Class 2b ·DRTECH Corporation·1 device

Digital Mammography system

Basic UDI-DI

EU MDD · Eu Md Class 2b ·DRTECH Corporation·1 device

HZ 2033753-1

Certificate

MDR QMS·DRTECH Corporation·TÜV Rheinland LGA Products GmbH

2195-MED-2108401

Certificate

MDD Annex II (excluding section 4)·DRTECH Corporation·Szutest Uygunluk Değerlendirme A.Ş.·2 Basic UDI-DIs

DRTECH Europe GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers·21 Devices

ΑΠΟΣΤΟΛΟΣ ΓΕΩΡΓ. ΠΑΠΟΥΔΗΣ ΚΑΙ ΥΙΟΣ ΑΝΩΝΥΜΟΣ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ ΑΝΤΙΠΡΟΣΩΠΕΙΕΣ-ΕΙΣΑΓΩΓΕΣ ΙΑΤΡΙΚΩΝ ΜΗΧΑΝΗΜΑΤΩΝ Α.Ε.

Importer

6 Manufacturers

Agfa NV

Importer

🇧🇪 Belgium·8 Manufacturers

Nano-Ditech Corporation

Manufacturer

🇺🇸 United States

Exdia TRF Plus

FDA registration

Precision Biosensor Inc. 2nd Factory·1 product·🇰🇷 South Korea

Nano-Checker 710

FDA registration

Precision Biosensor Inc. 2nd Factory·1 product·🇰🇷 South Korea

Fluoro-Checker TRF

FDA registration

Precision Biosensor Inc. 2nd Factory·1 product·🇰🇷 South Korea

Nano-Check TM DAT 5M Test

FDA registration

NANO-DITECH CORPORATION·5 products·🇺🇸 United States