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Sources: EU EUDAMED, US FDA
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Country: Taiwan
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Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tyson Bioresearch, Inc.
Manufacturer
🇹🇼 Taiwan·24 Basic UDI-DIs·24 Devices·1 Importer·Eurofins Electric & Electronics Finland Oy and Eurofins Electric & Electronics Finland Oy
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
FDA 510(k)
FDA Class 2
·Cardiovascular
Health & Life Corporation
Manufacturer
🇹🇼 Taiwan
Health & Life Co., Ltd
Manufacturer
🇹🇼 Taiwan·4 Basic UDI-DIs·4 Devices·3 Importers·TÜV Rheinland LGA Products GmbH
PE & LE Enterprise Ltd.
Manufacturer
🇹🇼 Taiwan
Nova Orthopedic & Rehabilitation Appliance Inc.
Manufacturer
🇹🇼 Taiwan
Teh Lin Prosthetic & Orthopaedic lnc
Manufacturer
🇹🇼 Taiwan·1 Importer
Master & Frank Enterprise Co., Ltd.
Manufacturer
🇹🇼 Taiwan
APOZA ENTERPRISE CO., LTD.
Manufacturer
🇹🇼 Taiwan·5 Basic UDI-DIs·15 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV
Wellong Instruments Co., Ltd.
Manufacturer
🇹🇼 Taiwan·2 Importers
Machan International Co., Ltd.
Manufacturer
🇹🇼 Taiwan·2 Basic UDI-DIs·24 Devices·1 Importer
Mediland Enterprise Corporation
Manufacturer
🇹🇼 Taiwan·11 Basic UDI-DIs·58 Devices·1 Importer
RADIRAD CO., LTD.
Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·1 Device
WS FAR IR MEDICAL CO., LTD.
Manufacturer
🇹🇼 Taiwan
HippoScreen Neurotech Corp
Manufacturer
🇹🇼 Taiwan·2 Basic UDI-DIs·2 Devices
APEXLENS CO., LTD.
Manufacturer
🇹🇼 Taiwan
Cuumed catheter medical co., Ltd.
Manufacturer
🇹🇼 Taiwan
JOSON-CARE ENTERPRISE CO., LTD.
Manufacturer
🇹🇼 Taiwan
Gemore Technology Co., Ltd.
Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·7 Devices