3,846 results · 12ms · 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.

Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

Fecal Occult Blood Rapid Test Cassette (Feces)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

Fecal Occult Blood Rapid Test Strip (Feces)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

Rotavirus Rapid Test Cassette (Feces)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

Sapovirus Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

Influenza A & B Ag Rapid Test Cassette (Swab)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

Influenza A & B Ag Rapid Test Cassette (Swab)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

NucleoSpin® Dx RNA Blood

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·MACHEREY-NAGEL GmbH & Co. KG·1 device

Sentosa SA C. diff PCR Test v2.0 (4x24)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BRAF V600 PCR Test (4x8)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BKV PCR Test (4X48)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BKV Quantitation Standards (2x13)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BKV Quantitation Controls (4x2)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BKV PCR Test (4x24)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BKV Controls (8x3)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Adellgene® Fragile X Screening 16 tests

Basic UDI-DI
EU IVDD · Eu Ivd General ·Blackhills Diagnostic Resources S.L.U.·1 device

MolYsis-SNplus™ IVD

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Molzym GmbH & Co.KG·2 devices

UMD-SelectNA™ CE IVD

Basic UDI-DI
EU IVDD · Eu Ivd General ·Molzym GmbH & Co.KG·1 device

UMD-SelectNA™ CE IVD

Basic UDI-DI
EU IVDD · Eu Ivd General ·Molzym GmbH & Co.KG·1 device