22 results
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18ms
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Sources: EU EUDAMED, US FDA
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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
DKK DAI-ICHI SHOMEI CO, LTD
FDA registration
DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan
PENTAX ULTRASOUND UPPER G.I. VIDEOSCOPE EG-3270UK
Device
EU MDD
·
Eu Md Class 2a
·HOYA Corporation ·On the market·32 countries
PENTAX Medical Ultrasound Upper G.I. Video Scope EG36-J10UR
Device
EU MDR
·
Eu Md Class 2a
·HOYA Corporation ·On the market·32 countries
PENTAX Medical Ultrasound Upper G.I. Video Scope EG34-J10U
Device
EU MDR
·
Eu Md Class 2a
·HOYA Corporation ·On the market·32 countries
Tissue-Tek VIP 6 AI
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sakura Seiki Co., Ltd.·1 device
PENTAX Medical Ultrasound Upper G.I. Video Scope
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·HOYA Corporation ·2 devices
PENTAX ULTRASOUND UPPER G.I. VIDEOSCOPE EG-3270UK
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HOYA Corporation ·1 device
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
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
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024