83 results · 9ms · Sources: EU EUDAMED, US FDA

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Intelligent Ultrasound Limited

Manufacturer
3 Importers·Kiwa Dare B.V. and Kiwa Dare B.V.

CRE 16-well

Device
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·On the market

CRE 16-well

Device
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·On the market

Limbus AI Inc.

Manufacturer
🇨🇦 Canada·Kiwa Dare B.V.

CRE Reference 24-well

Device
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·On the market

CRE Reference 24-well

Device
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·On the market

CRE EU 16-well

Device
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·On the market

CRE EU 16-well

Device
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·On the market

Step 1 tubes for CRE 16-well

Basic UDI-DI
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for CRE 16-well

Basic UDI-DI
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·1 device

Step 1 tubes for CRE Reference 24-well

Basic UDI-DI
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for CRE Reference 24-well

Basic UDI-DI
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·1 device

Step 1 tubes for CRE EU 16-well

Basic UDI-DI
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for CRE EU 16-well

Basic UDI-DI
EU IVDD · Eu Ivd General ·AusDiagnostics Pty Ltd·1 device

23M00184CRT01

Certificate
MDR QMS·Intelligent Ultrasound Limited·Kiwa Dare B.V.

21M00123CRT01

Certificate
MDR QMS·Limbus AI Inc.·Kiwa Dare B.V.

20M00066CRT04

Certificate
MDR QMS·Intelligent Ultrasound Limited·Kiwa Dare B.V.

Kryptonite Solutions

Manufacturer
🇮🇳 India·3 Basic UDI-DIs·3 Devices

Plasmapp Co., Ltd

Manufacturer
🇰🇷 South Korea·6 Basic UDI-DIs·7 Devices·2 Importers·MTIC InterCert S.r.l., MTIC InterCert S.r.l., and MTIC InterCert S.r.l.

KASHMIR SURGICAL INDIA PVT LTD

Manufacturer
🇮🇳 India