PureMDR GmbH

Authorized representative

🇩🇪 Germany·9 Manufacturers·21 Devices

Maggots, Medical

FDA classification

FDA Unclassified ·Maggots, Medical

Hettich Labinstrument

Importer

🇩🇰 Denmark·3 Manufacturers

SARS-CoV-2 & Influenza AB Antigen Combo Rapid Test Kit (LFIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

FLU A & B & SARS-Cov-2 & RSV& ADV Combo Rapid Test Device

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Gonorrhea Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Monkeypox Virus Antigen Rapid Test Device (Pus Swab)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Influenza A+B Rapid Test Cassette

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Influenza A+B Rapid Test Cassette

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Dengue IgG/IgM and NS1 Rapid Test Device

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Dengue IgG/IgM and NS1 Rapid Test Device

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device

Elers Medical Finland Oy

Importer

🇫🇮 Finland·6 Manufacturers

M.2020.106.14040

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·103 Basic UDI-DIs

FWS-WJ-008C Inner tube

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

Vertebroplasty auxiliary instrument

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

P099002

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

M.2020.106.14042

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·163 Basic UDI-DIs

M.2020.106.14045

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·47 Basic UDI-DIs

M.2020.106.13870

Certificate

MDD Annex II (excluding section 4)·Chongqing FWS Medical Device Co.,Ltd·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·84 Basic UDI-DIs