28 results · 26ms · Sources: EU EUDAMED, US FDA

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cobas 8000 modular analyzer series System Software Version 06-10

Device
EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

EYEVAN

Device
EU MDR · Eu Md Class 1 ·EYEVAN Inc.·On the market

Plasmaflo

Device
EU MDR · Eu Md Class 2b ·Asahi Kasei Medical Co., Ltd.·On the market·8 countries

ELLTEC Co., Ltd.

Manufacturer
🇯🇵 Japan·1 Importer

YAC ELEX Co.,LTD.

Manufacturer
🇯🇵 Japan

JPS CORPORATION

Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device

MANI, INC.

Manufacturer
🇯🇵 Japan·25 Importers·TÜV Rheinland LGA Products GmbH

T.G. Medical Inc.

Manufacturer
🇯🇵 Japan

YAMAHACHI DENTAL MFG., CO.

Manufacturer
🇯🇵 Japan·1 Importer

Kono Seisakusho Co., Ltd.

Manufacturer
🇯🇵 Japan

Minaris Medical Co., Ltd.

Manufacturer
🇯🇵 Japan·5 Basic UDI-DIs·6 Devices·2 Importers

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

FDA Enforcement
Class II ·Terminated·Nakanishi Inc.·October 31, 2018

cobas 8000 modular analyzer series System Software Version 06-10

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·1 device

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..

FDA Enforcement
Class II ·Terminated·Nakanishi Inc.·October 31, 2018

NailLift

Device
EU MDR · Eu Md Class 1 ·JPS CORPORATION·On the market·3 countries

EXTEL HEMO・AUTO HS Control

Device
EU IVDD · Eu Ivd General · Minaris Medical Co., Ltd. ·On the market·3 countries

EXTEL HEMO・AUTO HS Latex

Device
EU IVDD · Eu Ivd General · Minaris Medical Co., Ltd. ·On the market·3 countries

EXTEL HEMO・AUTO MC Collection Picker

Device
EU IVDR · Eu Ivd Class A · Minaris Medical Co., Ltd. ·On the market·2 countries

EXTEL HEMO・AUTO MC Collection Picker

Device
EU IVDR · Eu Ivd Class A · Minaris Medical Co., Ltd. ·On the market·2 countries

EXTEL HEMO・AUTO HS Calibrator

Device
EU IVDD · Eu Ivd General · Minaris Medical Co., Ltd. ·On the market·3 countries