EFX - BEUDAMED

AFX Introducer

Device

EU MDD · Eu Md Class 3 ·Endologix LLC·On the market·17 countries

COVISION

Device

EU MDD · Eu Md Class 3 ·Covision Medical Technologies Ltd.·On the market·32 countries

Powerbone

Device

EU MDD · Eu Md Class 3 ·Bonegraft Biomaterials Co.·On the market·32 countries

Bioptimal Central Venous Catheter and Catherization Kit

Device

EU MDD · Eu Md Class 3 ·Bioptimal International PTE. LTD.·On the market·9 countries

AYSAM

Device

EU MDD · Eu Md Class 2b ·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·On the market·32 countries

AFX Introducer System

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Endologix LLC·1 device

Powerbone Synthetic Bone Graft Dental Putty 0,3 cc

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Bonegraft Biomaterials Co.·1 device

ST.LEGER NEO MOBILE BEARING C/R TIBIAL INSERT (XL) 55mm 17mm

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Covision Medical Technologies Ltd.·1 device

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer

🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

1434-MDD-166/2025

Certificate

MDD Annex II Section 4·Rontis Corporation SA·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs