Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Manufacturer

🇨🇳 China·334 Basic UDI-DIs·1887 Devices·29 Importers·SGS Belgium NV, SGS Belgium NV, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

ITH 1344699 1

Certificate

MDR QMS·Intersurgical SpA·TUV Rheinland Italia SRL

ITH 1344294 1

Certificate

MDR QMS·I.A.C.E.R. Srl·TUV Rheinland Italia SRL

ITH 1343248 1

Certificate

MDR QMS·Hydra srl·TUV Rheinland Italia SRL

HZ 2093717-1

Certificate

MDR QMS·J. MORITA MFG. CORP.·TÜV Rheinland LGA Products GmbH

ITH 2378440 1

Certificate

MDR QMS·DataRiver S.r.l.·TUV Rheinland Italia SRL

ITH 2426703 1

Certificate

MDR QMS·Comerge AG·TUV Rheinland Italia SRL

ITH 2486145 1

Certificate

MDR QMS·B. & B. Dental S.r.l.·TUV Rheinland Italia SRL

ITH 1343070 1

Certificate

MDR QMS·IONCLINICS & DEIONIC, S.L.·TUV Rheinland Italia SRL

HZ 1785176-1

Certificate

MDR QMS·GEOMED Medizin-Technik GmbH & Co. KG·TÜV Rheinland LGA Products GmbH

HZ 1450174-1

Certificate

MDR QMS·BioCer Entwicklungs-GmbH·TÜV Rheinland LGA Products GmbH

HZ 2182322-1

Certificate

MDR QMS·ShenZhen ZhengKang Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH

28620177096

Certificate

MDR QMS·Amalgam Rx, Inc·Intertek Medical Notified Body AB

HX 1804155-1

Certificate

IVDR QMS·Dominion Biologicals Limited·TÜV Rheinland LGA Products GmbH

ITH 1450769 1

Certificate

MDR QMS·Imaginalis Srl·TUV Rheinland Italia SRL

ITH 2308229 1

Certificate

MDR QMS·MEDILAB-PD SRL·TUV Rheinland Italia SRL

ITH 1024597 1

Certificate

MDR QMS·Asensus Surgical Italia S.r.l.·TUV Rheinland Italia SRL

M.2024.MDR.1036

Certificate

MDR QMS·Beijing Target Medical Technologies Inc.·UDEM Adriatic d.o.o.