328 results · 18ms · Sources: EU EUDAMED, US FDA

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GB Lifecare Co., Ltd.

Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH

ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS

Device
EU MDD · Eu Md Class 2b ·Woo Young Medical Co., Ltd.·On the market·9 countries

ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS

Device
EU MDD · Eu Md Class 2b ·Woo Young Medical Co., Ltd.·On the market·9 countries

Gmate® Blood Glucose Test Strip

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·GB Lifecare Co., Ltd.·1 device

Gmate® Origin

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·GB Lifecare Co., Ltd.·1 device

Accufuser Omnibus

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Woo Young Medical Co., Ltd.·1 device

HL60145538

Certificate
IVDD Annex IV (excluding sections 4, 6)·GB Lifecare Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

Iridex Corporation

Manufacturer
🇺🇸 United States·4 Basic UDI-DIs·54 Devices·1 Importer

Sky Labs Inc.

Manufacturer
🇰🇷 South Korea

Changsha Sinocare Inc.

Manufacturer
🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

GaleMed Corporation

Manufacturer
🇹🇼 Taiwan·23 Basic UDI-DIs·94 Devices·3 Importers

Changsha Sinocare Inc.

Manufacturer
🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH

RespiraSource, OPC

Manufacturer
🇵🇭 Philippines

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Device
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·On the market

ALANINE AMINO-TRANSFERASE

Device
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·On the market

CHOLESTEROL

Device
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·On the market

C-REACTIVE PROTEIN - RT & POC

Device
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·On the market

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Device
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·On the market

RHEUMATOID FACTORS

Device
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·On the market

GLUCOSE TEST STRIPS

Device
EU IVDD · Eu Ivd Self Testing ·Changsha Sinocare Inc.·On the market