Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer

🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

H-103 IGG, H-104 IGA, H-105 IGM

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

FDA 510(k)

FDA Class 2 ·Immunology

RANDOX MICROALBUMIN

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO RABBIT IMMUNOGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGG ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERA TO RABBIT IMMUNOGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

FLUORESCEIN CONJUGATED IMMUNOGLOBIN-

FDA 510(k)

FDA Class 2 ·Immunology

MICROALBUMIN REAGENT SET AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

Zhejiang YiGao Medical Technology Co., Ltd.

Manufacturer

🇨🇳 China·12 Basic UDI-DIs·191 Devices

POLYTOUCH Co., Ltd.

Manufacturer

🇰🇷 South Korea·1 Basic UDI-DI·1 Device·2 Importers·SGS Belgium NV

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems

Ophthalmic Electric Table

FDA UDI

MDT SP Z O O·05907642694107·