Leadtek Research Inc.

Manufacturer

🇹🇼 Taiwan

Javelin Medical

Manufacturer

🇮🇱 Israel

ENTire Medical

Manufacturer

🇮🇱 Israel

HD1137176

Certificate

MDD Annex II (excluding section 4)·JSC Vilimed·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

ATF

Device

EU MDR · Eu Md Class 1 ·Arya Teb Firouz Co.·On the market·2 countries

ATF

Device

EU MDR · Eu Md Class 2a ·Arya Teb Firouz Co.·On the market·2 countries

ATF

Device

EU MDR · Eu Md Class 2a ·Arya Teb Firouz Co.·On the market·2 countries

ATF

Device

EU MDR · Eu Md Class 2b ·Arya Teb Firouz Co.·On the market·2 countries

CHEN HUEY-JEN

Importer

🇫🇷 France

BTL Industries JSC

Importer

🇧🇬 Bulgaria

Lavage, Jet

FDA classification

FDA Class 2 ·Lavage, Jet

Apolipoprotein A1 Kit (Turbidimetry Method)

Basic UDI-DI

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

CE 619995

Certificate

MDD Annex II (excluding section 4)·OrbusNeich Medical, B.V.·BSI Group The Netherlands B.V.·181 Basic UDI-DIs

Collagen Wound Dressing

Basic UDI-DI

EU MDR · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·20 devices

Guided Tissue and Bone Regeneration Membrane and Plug

Basic UDI-DI

EU MDR · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·32 devices

MULTILINE

Basic UDI-DI

EU MDD · Eu Md Class 2b ·SIA "LINLINE Medical Systems"·1 device

COLTRIX® CartiRegen, Collaju®

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Ubiosis·1 device

TomoCon GO

Basic UDI-DI

EU MDD · Eu Md Class 1 ·TatraMed Software s.r.o.·1 device

Hyprojoint

Basic UDI-DI

EU MDR · Eu Md Class 3 ·Bloomage Biotechnology Corp.,Ltd.·1 device