22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DSP for cobas 8100
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
OC-1A
Device
EU MDR
·
Eu Md Class 1
·Takagi seiko·On the market·32 countries
KOWA DR-1a
FDA 510(k)
FDA Class 2
·Ophthalmic
CYBERDYNE Inc.
Manufacturer
🇯🇵 Japan·TÜV Rheinland LGA Products GmbH
Echo Electricity Co., Ltd
Manufacturer
🇯🇵 Japan·SGS Belgium NV
PreXion Corporation
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
JM Ortho Corporation
Manufacturer
🇯🇵 Japan
J. MORITA TOKYO MFG. CORP.
Manufacturer
🇯🇵 Japan
AUTO REFRACTOMETER AR-1a
Device
EU MDR
·
Eu Md Class 2a
·NIDEK.CO.Ltd.,·On the market·32 countries
OLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer
🇯🇵 Japan·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
AUTO REF/KERATOMETER ARK-1a
Device
EU MDR
·
Eu Md Class 2a
·NIDEK.CO.Ltd.,·On the market·32 countries
ODONTOLOGY DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 2b
·PreXion Corporation·No longer on the market
UA-CUFFBOXSL-EC
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·A&D Company, Limited·1 device
AR-1,AR-1a,AR-1s,HandyRef,AR-F
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·NIDEK.CO.Ltd.,·5 devices
ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·NIDEK.CO.Ltd.,·6 devices
DZ 2081569-1
Certificate
MDR QA·CYBERDYNE Inc.·TÜV Rheinland LGA Products GmbH
DZ 2158445-1
Certificate
MDR QA·OLYMPUS MEDICAL SYSTEMS CORP.·TÜV Rheinland LGA Products GmbH
JP24/00000218
Certificate
MDR QA·Echo Electricity Co., Ltd·SGS Belgium NV