41 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Kai Industries Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·6 Devices·4 Importers·TÜV Rheinland LGA Products GmbH
Dry Incubator / EC6S-230MR
Device
EU MDR
·
Eu Md Class 2a
·ASTEC CO.,Ltd·On the market·3 countries
Protex Probe Cover Dry
Device
EU MDR
·
Eu Md Class 2b
·Sagami Rubber Industries Co., Ltd.·On the market·1 country
DRI OCT Triton (plus)
Device
EU MDR
·
Eu Md Class 2a
·TOPCON CORPORATION·On the market·32 countries
Dry Shipper DR-2DSE
Device
EU MDD
·
Eu Md Class 2a
·Taiyo Nippon Sanso Corporation·On the market·1 country
DRI OCT Triton
FDA 510(k)
FDA Class 2
·Ophthalmic
3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON
Device
EU MDR
·
Eu Md Class 2a
·TOPCON CORPORATION·On the market·2 countries
DRY LASER IMAGER, DRYPRO MODEL 832
FDA 510(k)
FDA Class 2
·Radiology
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
FDA 510(k)
FDA Class 2
·Radiology
DERMAL CURETTE 2 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 7 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 5 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 4 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE 3 mm
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
DERMAL CURETTE
Device
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·On the market·29 countries
Dry Incubator
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·ASTEC CO.,Ltd·1 device
Dry Shipper DR-2DSE
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Taiyo Nippon Sanso Corporation·1 device
DERMAL CURETTE
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·6 devices
HZ 2066395-1
Certificate
MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023