Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR

1984-MDD-17-461

Certificate

MDD Annex II (excluding section 4)·KOEK BİYOTEKNOLOJİ BİYOMÜHENDİSLİK VE MEDİKAL HİZ. SAN. TİC. A.Ş.·Kiwa Belgelendirme Hizmetleri A.Ş.·6 Basic UDI-DIs

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM

C-Peptide(CLIA)、C-Peptide Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Neuro Cochlear Implant System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

HASVET MEDİKAL YAZILIM SAĞ. HİZ. SAN. VE TİC. A.Ş.

Importer

🇹🇷 Türkiye

Centrifuge 5427R

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Eppendorf SE·3 devices

STERİLİZASYON MEDİKAL SAĞ. HİZ. GIDA SAN. VE TİC. LTD. ŞTİ.

Importer

🇹🇷 Türkiye

HOZ MEDI WERK Produktions- und Vertriebs GmbH & Co. KG

Importer

🇩🇪 Germany

STERİLİZASYON MEDİKAL SAĞ. HİZ. GIDA SAN. VE TİC. LTD. ŞTİ.

Authorized representative

🇹🇷 Türkiye

Medikon Sağlık Turizm Seyahat Dan. Hiz. İth. İhr. ve Tic. Ltd. Şti.

Importer

🇹🇷 Türkiye

STERİLİZASYON MEDİKAL SAĞ. HİZ. GIDA SAN. VE TİC. LTD. ŞTİ.

System producer

🇹🇷 Türkiye

Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. Ş.

System producer

🇹🇷 Türkiye

Zoustech S.L.

Authorized representative

🇪🇸 Spain·29 Manufacturers·1039 Devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901

Hospital Services Limited

Importer

🇮🇪 Ireland·10 Manufacturers

Duomed France Endoscopie

Importer

🇫🇷 France·9 Manufacturers