59 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

fPSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

PSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

PSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

fPSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

Hematoxylin and Eosin (H&E) stain

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Papanicolaou Stain

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Eosin Stain

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Buffer Solution

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Preservative Fluid (For Non-Gynecological Sample)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Preservative Fluid (For Gynecological Sample)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Gradient Media

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Hematoxylin Solution

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

COVID-19 and Influenza A/B Antigen Test Kit for self-testing

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device

HIV Rapid Test Device (Whole blood/Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

Rapid SARS-CoV-2&Flu A&Flu B Antigen Test (Colloidal Gold)/ Nasal Swab

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Suny (Xiamen) Biotechnology Co., Ltd.·1 device