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Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·EBK RIA ASSAY/ETI-EBK

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-AB-EBK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-EBK PLUS ASSAY

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

VACUUM CUP (004SD)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

REHASTIM 2, REHAMOVE 2

FDA 510(k)
FDA Class 2 ·Neurology

SWIFT DELIVERY PRODUCT #300

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SWIFT LOW PROFILE CUP (PRO CUP)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

RehaStim 2

FDA 510(k)
FDA Class 2 ·Neurology

JIAJIAN SELF-ADHESIVE ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

JIAJIAN ACUPUNCTURE NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

REHASTIM & REHAMOVE

FDA 510(k)
FDA Class 2 ·Neurology

REHASTIM 2, ERIGOPRO (FES)

FDA 510(k)
FDA Class 2 ·Neurology

RESTLESS LEG DEVICE

FDA 510(k)
FDA Class 1 ·Physical Medicine

EXPERIENCE

FDA UDI
Gc Orthodontics America Inc.·D788202CC5X95461·EXP CCO 022 UL 5-5 ROTH L2-2 HK 345

VIVA (HBF-222T-EBK)

Device
EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·22 countries

OHDAE Corporation

Manufacturer
🇰🇷 South Korea·9 Basic UDI-DIs·9 Devices

VASSEN

Manufacturer
🇰🇷 South Korea