11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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HAKKO CO., LTD.
Manufacturer
🇯🇵 Japan·2 Basic UDI-DIs·2 Devices·3 Importers·BSI Group The Netherlands B.V.
SPOTCHEM II GOT/AST
Basic UDI-DI
EU IVDD
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Eu Ivd General
·ARKRAY Factory, Inc.·1 device
SPOTCHEM II GOT/AST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·1 device
SPOTCHEM D AST (GOT)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·1 device
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014
The Lab 004 AST (GOT)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·1 device
SHEARING BIOPSY NEEDLES
Device
EU MDD
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Eu Md Class 2a
·HAKKO CO., LTD.·On the market·1 country
MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE
Device
EU MDD
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Eu Md Class 2a
·HAKKO CO., LTD.·On the market·1 country
CE 549032
Certificate
MDD Annex II (excluding section 4)·HAKKO CO., LTD.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs
SONOPSY C1_16G×170 ㎜
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HAKKO CO., LTD.·1 device
LAP PROTECTOR - FF1210H
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HAKKO CO., LTD.·1 device