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

Spatz3 Adjustable Balloon System

Device

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

Spatz3 Adjustable Balloon System Insertion Kit

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·1 device

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

Ditron Dental Ltd.

Manufacturer

🇮🇱 Israel

IOPtima Ltd.

Manufacturer

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

ARUM DENTISTRY Co., Ltd.

Manufacturer

🇰🇷 South Korea·1 Importer

EyeYon Medical Ltd.

Manufacturer

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

Medscope Biotech Co., Ltd.

Manufacturer

🇹🇼 Taiwan·2 Importers

Eitan Medical Ltd

Manufacturer

🇮🇱 Israel·1 Basic UDI-DI·1 Device·6 Importers

O-Two Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·1 Importer

CathWorks Ltd.

Manufacturer

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

Plas-Free Ltd

Manufacturer

🇮🇱 Israel

Biodenta Swiss AG

Manufacturer

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

InfinetaMed AG

Manufacturer

🇨🇭 Switzerland

MFC Global Ltd.

Manufacturer

🇮🇱 Israel

Butterfly Medical Ltd.

Manufacturer

🇮🇱 Israel

Medical Systems and Devices International Ltd.

Manufacturer

🇮🇱 Israel

Digma Medical Ltd.

Manufacturer

🇮🇱 Israel

Infinitum Eta Ltd.

Manufacturer

🇮🇱 Israel