Biodenta Swiss AG

Manufacturer

🇨🇭 Switzerland·5 Basic UDI-DIs·5 Devices·TÜV Rheinland LGA Products GmbH

IOPtima Ltd.

Manufacturer

🇮🇱 Israel·1 Basic UDI-DI·1 Device·1 Importer·DEKRA Certification B.V.

EyeYon Medical Ltd.

Manufacturer

🇮🇱 Israel·2 Basic UDI-DIs·2 Devices·2 Importers·DNV MEDCERT GmbH

VADI Medical Technology Co., Ltd.

Manufacturer

🇹🇼 Taiwan·5 Basic UDI-DIs·5 Devices·DNV Product Assurance AS

CathWorks Ltd.

Manufacturer

🇮🇱 Israel·2 Basic UDI-DIs·2 Devices·1 Importer·DEKRA Certification B.V.

Spatz FGIA Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

3901646CE01

Certificate

MDD Annex II (excluding section 4)·CathWorks Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

2125546CE01

Certificate

MDD Annex II (excluding section 4)·IOPtima Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

7406GB410210510A

Certificate

MDD Annex II (excluding section 4)·EyeYon Medical Ltd.·DNV MEDCERT GmbH·2 Basic UDI-DIs

9909-2017-CE-RGC-NA-PS

Certificate

MDD Annex II (excluding section 4)·VADI Medical Technology Co., Ltd.·DNV Product Assurance AS·5 Basic UDI-DIs

HD 60138182 0001

Certificate

MDD Annex II (excluding section 4)·Biodenta Swiss AG·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

FFRangio

Device

EU MDD · Eu Md Class 2a ·CathWorks Ltd.·On the market·1 country

Hyper-CL

Device

EU MDD · Eu Md Class 2a ·EyeYon Medical Ltd.·On the market·3 countries

EndoArt®

Device

EU MDD · Eu Md Class 2b ·EyeYon Medical Ltd.·On the market·4 countries

RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

Device

EU MDD · Eu Md Class 2a ·VADI Medical Technology Co., Ltd.·On the market·32 countries

RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

Device

EU MDD · Eu Md Class 2a ·VADI Medical Technology Co., Ltd.·On the market·32 countries

STANDARD BREATHING CIRCUITS - OTHER

Device

EU MDD · Eu Md Class 2a ·VADI Medical Technology Co., Ltd.·On the market·32 countries

STANDARD BREATHING CIRCUITS - OTHER

Device

EU MDD · Eu Md Class 2a ·VADI Medical Technology Co., Ltd.·On the market·32 countries

Closure Screw

Device

EU MDD · Eu Md Class 2b ·Biodenta Swiss AG·On the market·2 countries