Huons Meditech Co., Ltd.

Manufacturer

🇰🇷 South Korea·4 Basic UDI-DIs·4 Devices·SGS Belgium NV and TÜV SÜD Product Service GmbH

Genewel Co., Ltd.

Manufacturer

🇰🇷 South Korea·1 Basic UDI-DI·2 Devices

M.I.Tech Co., Ltd

Manufacturer

🇰🇷 South Korea·809 Basic UDI-DIs·809 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Nunaps Inc.

Manufacturer

🇰🇷 South Korea

PAPRICA LAB CO.,LTD.

Manufacturer

🇰🇷 South Korea

AB Medical, Inc.

Manufacturer

🇰🇷 South Korea·32 Basic UDI-DIs·32 Devices

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM

ARROW

FDA UDI

TELEFLEX INCORPORATED·30801902134531·UltraCath(TM) Continuous Nerve Block Kit

ARROW

FDA UDI

TELEFLEX INCORPORATED·10801902134537·UltraCath(TM) Continuous Nerve Block Kit

INSPECS LTD

FDA registration

INSPECS LTD·1 product·🇬🇧 United Kingdom

Minipack/Vitalmax

FDA registration

PACETECH·1 product·🇺🇸 United States

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

AMBI-DEX (LATEX EXAMINATION GLOVES)

FDA 510(k)

FDA Class 1 ·General Hospital

Xclose Plus

FDA UDI

Kr Medical Technologies LLC·00860323000206·TISSUE REPAIR SYSTEM WITH INVISILOC TECHNOLOGY

SHIATSU MASSAGER

FDA 510(k)

FDA Class 1 ·Physical Medicine

AAMEDIX GLOVE SDN BHD

FDA registration

AAMEDIX GLOVE SDN BHD·1 product·🇲🇾 Malaysia

PHLOXINE B

FDA registration

AVANTOR PERFORMANCE MATERIALS, LLC·1 product·🇺🇸 United States

ANILINE BLUE/WS

FDA registration

AVANTOR PERFORMANCE MATERIALS, LLC·1 product·🇺🇸 United States

AURAMINE O

FDA registration

AVANTOR PERFORMANCE MATERIALS, LLC·1 product·🇺🇸 United States

ORANGE G CERTIFIED OR

FDA registration

AVANTOR PERFORMANCE MATERIALS, LLC·1 product·🇺🇸 United States