HX 2028254-1

Certificate

IVDR QMS·DFI Co.,Ltd.·TÜV Rheinland LGA Products GmbH

CLIP ON PLASTIC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·WENZHOU ZHICHENG OPTICAL MFY. CO.,LTD·1 device

clip on metal

Basic UDI-DI

EU MDR · Eu Md Class 1 ·WENZHOU ZHICHENG OPTICAL MFY. CO.,LTD·1 device

SPECTACLE FRAMES

Basic UDI-DI

EU MDR · Eu Md Class 1 ·WENZHOU ZHICHENG OPTICAL MFY. CO.,LTD·2 devices

SPECTACLE FRAMES

Basic UDI-DI

EU MDR · Eu Md Class 1 ·WENZHOU ZHICHENG OPTICAL MFY. CO.,LTD·2 devices

Reading Glasses

Basic UDI-DI

EU MDR · Eu Md Class 1 ·WENZHOU ZHICHENG OPTICAL MFY. CO.,LTD·1 device

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

FDA 510(k)

FDA Class 2 ·Orthopedic

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVASCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450, E-musb

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steriking® LT-Blueline Pouches with Tyvek®

FDA 510(k)

FDA Class 2 ·General Hospital

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Icare ic100

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Steriking LT-Blueline Pouches with Tyvek

FDA 510(k)

FDA Class 2 ·General Hospital