Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

System, Suction, Lipoplasty

FDA classification

FDA Class 2 ·System, Suction, Lipoplasty

ProGRP（CLIA）、ProGRP Calibrators、ProGRP Control

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

VID74-

Basic UDI-DI

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

CVD000423

Certificate

MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'

CVD000523

Certificate

MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'

CSQ000823

Certificate

MDR QMS·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'

QCT-0066-17

Certificate

MDD Annex II (excluding section 4)·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·68 Basic UDI-DIs

EPG-0066-17

Certificate

MDD Annex II Section 4·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·28 Basic UDI-DIs

CVD 0004-23

Certificate

MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

CVD 0005-23

Certificate

MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

EPG-0065-17

Certificate

MDD Annex II Section 4·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·7 Basic UDI-DIs

EPG-0064-17

Certificate

MDD Annex II Section 4·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·34 Basic UDI-DIs

QCT-066-17

Certificate

MDD Annex II (excluding section 4)·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

CS Active

Authorized representative

🇱🇻 Latvia·19 Manufacturers·132 Devices

MePro FH-Handels GmbH

Importer

🇩🇪 Germany

ANTEX MEDI SOLUTION

Authorized representative

🇩🇪 Germany·26 Manufacturers·11971 Devices

Maggots, Medical

FDA classification

FDA Unclassified ·Maggots, Medical

HPT-M24-SHD; RLT-MS25-WAK; RLT-MS25-WAK02; RLT-MS23-WBP; RLT-MS25-BT01; RLT-MS25-BT02;

FDA registration

DONG GUAN TOP YAO INDUSTRY CO.,LTD·1 product·🇨🇳 China

Leeches, Medicinal

FDA classification

FDA Unclassified ·Leeches, Medicinal