17 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
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
DKK DAI-ICHI SHOMEI CO, LTD
FDA registration
DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan
DERMAL CURETTE
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Kai Industries Co., Ltd.·6 devices
Tissue-Tek VIP 6 AI
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sakura Seiki Co., Ltd.·1 device
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
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023