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.

Perflow Medical Ltd.

Manufacturer

🇮🇱 Israel·11 Basic UDI-DIs·21 Devices·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

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

Perflow Medical Ltd.

Manufacturer

🇮🇱 Israel·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

Eitan Medical Ltd

Manufacturer

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

Synergy Spine Solutions Inc.

Manufacturer

🇺🇸 United States·24 Basic UDI-DIs·24 Devices·GMED SAS

O-Two Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·1 Importer

EndoStream Medical Ltd

Manufacturer

🇮🇱 Israel·1 Importer

Hemo Bioengineering Pte. Ltd.

Manufacturer

🇸🇬 Singapore

Rapid Medical Ltd

Manufacturer

🇮🇱 Israel·1 Importer

G&G Biotechnology Ltd.

Manufacturer

🇮🇱 Israel

CathWorks Ltd.

Manufacturer

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

Datum Dental Ltd.

Manufacturer

🇮🇱 Israel