AMERSE

FDA 510(k)

FDA Class 1 ·General Hospital

ESI MODEL MS-103

FDA 510(k)

FDA Class 2 ·Neurology

ALSA-KLENZ

FDA 510(k)

FDA Class 1 ·General Hospital

VESPHENE II

FDA 510(k)

FDA Class 1 ·General Hospital

A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MANUAL SURGICAL INSTRUMENTS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CARDIOPULMONARY SUPPORT (CPS) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OEM MULTI-VAC POWERED SUCTION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

HARRIS CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iXensor Co., Ltd.

Manufacturer

🇹🇼 Taiwan·8 Basic UDI-DIs·8 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Shanghai Chemtron Biotech Co., Ltd.

Manufacturer

🇨🇳 China·15 Basic UDI-DIs·15 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Omixon Biocomputing Ltd.

Manufacturer

🇭🇺 Hungary·22 Basic UDI-DIs·24 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

hangzhou lysun biotechnology co.,ltd

Manufacturer

🇨🇳 China·41 Basic UDI-DIs·41 Devices·2 Importers·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Jiangsu Bioperfectus Technologies Co., Ltd.

Manufacturer

🇨🇳 China·216 Basic UDI-DIs·219 Devices·5 Importers·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Tyson Bioresearch, Inc.

Manufacturer

🇹🇼 Taiwan·24 Basic UDI-DIs·24 Devices·1 Importer·Eurofins Electric & Electronics Finland Oy and Eurofins Electric & Electronics Finland Oy

General Life Biotechnology Co., Ltd.

Manufacturer

🇹🇼 Taiwan·72 Basic UDI-DIs·72 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Helixgen (GUANGZHOU) Co., Ltd.

Manufacturer

🇨🇳 China·2 Basic UDI-DIs·2 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

IQ Products BV

Manufacturer

🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.

Gaobeidian PRISES Biotechnology Co., Ltd

Manufacturer

🇨🇳 China·6 Basic UDI-DIs·6 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH