Spatz FGIA Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Spatz3 Adjustable Balloon System

Device

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

Circulation Promoter Pro

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Guangzhou Xinbo Electronic Co.,Ltd·1 device

Neck Pain Pro

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Guangzhou Xinbo Electronic Co.,Ltd·1 device

GenePure Pro Nucleic Acid Purification System

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Hangzhou Bioer Technology Co., Ltd.·1 device

Proinsulin(Pro-INS) Detection Kit(CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

Upper limb rehabilitation Equipment（ArmMotus M2 Pro）

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Changsha Fourier Medical Technology Co.,Ltd.·1 device

Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer

Basic UDI-DI

EU IVDD · Eu Ivd General ·Acon Biotech (Hangzhou) Co., Ltd.·1 device

N-terminal Pro-B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

N-terminal Pro Brain Natriuretic Peptide(NT-proBNP) Detection Kit(CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

N-terminal Pro-B-type Natriuretic Peptide test (Up-converting Phosphor Technology)

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

Spatz3 Adjustable Balloon System Insertion Kit

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·1 device

Cardiac Troponin I /N-terminal Pro-B-type Natriuretic Peptide combination test (Up-converting Phosphor Technology)

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI