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

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CMR Surgical Limited

Manufacturer

Raphael 707-PR

Device
EU MDR · Eu Md Class 1 ·YOUNG IL M Co., Ltd.·On the market·1 country

CMR Phantoms

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Resonance Health Analysis Services·3 devices

MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Device
EU MDR · Eu Md Class 2b ·Huma Therapeutics Limited·On the market·32 countries

Raphael 707-PR

Basic UDI-DI
EU MDR · Eu Md Class 1 ·YOUNG IL M Co., Ltd.·1 device

Huma

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Huma Therapeutics Limited·1 device

Intelligent Ultrasound Limited

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

ZENA MAX BCR/ABL Major Real Time PCR Quantitative Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Advanced Molecular Diagnostics Ltd·1 device

Huma Therapeutics Limited

Manufacturer
1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

Huma Therapeutic Limited

Manufacturer
DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

CliniMed Limited

Manufacturer
13 Basic UDI-DIs·61 Devices·SGS Belgium NV

Europlaz Technologies Ltd.

Manufacturer
1 Importer·SGS Belgium NV

Limbus AI Inc.

Manufacturer
🇨🇦 Canada·Kiwa Dare B.V.

Asia Connection Co., Ltd.

Manufacturer
🇹🇼 Taiwan·2 Basic UDI-DIs·3 Devices·3 Importers·SGS Belgium NV

Outside In (Cambridge) Ltd trading as Lumie

Manufacturer
1 Importer·SGS Belgium NV

Takaso Rubber Products Sdn Bhd

Manufacturer
🇲🇾 Malaysia·SGS Belgium NV

SEOIL PACIFIC CORP.

Manufacturer
🇰🇷 South Korea·6 Basic UDI-DIs·6 Devices·3 Importers·SGS Belgium NV and Szutest Uygunluk Değerlendirme A.Ş.

GB24/00000155

Certificate
MDR QMS·Outside In (Cambridge) Ltd trading as Lumie·SGS Belgium NV

GB24/00000200

Certificate
MDR QMS·Europlaz Technologies Ltd.·SGS Belgium NV

1000164455

Certificate
MDR QMS·Huma Therapeutics Limited·DQS Medizinprodukte GmbH