FILTRYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Urease, Photometric, Urea Nitrogen

FDA classification

FDA Class 2 ·Urease, Photometric, Urea Nitrogen

Beta-2-Glycoprotein I, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Beta-2-Glycoprotein I, Antigen, Antiserum, Control

Folate(CLIA)、Folate Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Accessories kit - Laser Dentistry

Basic UDI-DI

EU MDR · Eu Md Class 1 ·1 device

Specific Protein Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

XL-400

FDA registration

JAS Diagnostics/Drew Scientific·8 products·🇺🇸 United States

IDN (INSTITUT DIETETIQUE ET NUTRITION)

Authorized representative

🇫🇷 France·1 Manufacturer

LDN Labor Diagnostika Nord GmbH & Co. KG

Importer

🇩🇪 Germany

DN FORMED Brno s.r.o.

Importer

🇨🇿 Czechia·1 Manufacturer

External Limb Prosthetic Component Accessory-Prosthetics Knee joint

Basic UDI-DI

EU MDR · Eu Md Class 1 ·KEN DALL ENTERPRISE CO., LTD.·24 devices

PICCOLO 9-CHEM REAGENT ROTOR

FDA registration

ABAXIS, INC.·9 products·🇺🇸 United States

CHIRASTAR KDT, s.r.o.

System producer

🇨🇿 Czechia

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC.KAPPA 400 SERIES PACEMAKERS

EF LINE

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ORTHOPLUS·85 devices

u110101

Certificate

MDD Annex II (excluding section 4)·Innolatex Sdn. Bhd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

MY19/1811030190

Certificate

MDD Annex II (excluding section 4)·Nulatex Sdn. Bhd.·SGS Belgium NV·89 Basic UDI-DIs

MT19/1811030190

Certificate

MDD Annex II (excluding section 4)·Nulatex Sdn. Bhd.·SGS Belgium NV·2 Basic UDI-DIs

MY/191811030190

Certificate

MDD Annex II Section 4·Nulatex Sdn. Bhd.·SGS Belgium NV·1 Basic UDI-DI

G1 104748 0002

Certificate

MDD Annex II (excluding section 4)·Innolatex Sdn. Bhd.·TÜV SÜD Product Service GmbH·48 Basic UDI-DIs