33 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Taiwan
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EBM Technologies Inc.
Manufacturer
🇹🇼 Taiwan·2 Basic UDI-DIs·2 Devices·DNV Product Assurance AS
EBM TECHNOLOGIES, INC.
FDA registration
EBM TECHNOLOGIES, INC.·5 products·🇹🇼 Taiwan
PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
Device
EU MDD
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Eu Md Class 2b
·EBM Technologies Inc.·On the market·1 country
PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
Device
EU MDD
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Eu Md Class 2a
·EBM Technologies Inc.·On the market·1 country
aZure Lance Drill, 2mm
Device
EU MDR
·
Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
VSOTG
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·EBM Technologies Inc.·1 device
SoliPACS
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·EBM Technologies Inc.·1 device
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
FDA Enforcement
Class II
·Terminated·EMG Technology Co., Ltd.·September 24, 2014
aZure E-System Twist Drill, 2 mm (D) x 8.5-15 mm (L)
Device
EU MDR
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Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
13354-2018-CE-RGC-NA
Certificate
MDD Annex II (excluding section 4)·EBM Technologies Inc.·DNV Product Assurance AS·2 Basic UDI-DIs
aZure C & E System Twist Drill, 2 mm (D) x 8.5 mm (L), 9.5 mm Drill Length
Device
EU MDR
·
Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
aZure C & E System Twist Drill, 2 mm (D) x 15 mm (L), 16 mm Drill Length
Device
EU MDR
·
Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
aZure C & E System Twist Drill, 2 mm (D) x 13 mm (L), 14 mm Drill Length
Device
EU MDR
·
Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
aZure C & E System Twist Drill, 2 mm (D) x 11.5 mm (L), 12.5 mm Drill Length
Device
EU MDR
·
Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
aZure C & E System Twist Drill, 2 mm (D) x 10 mm (L), 11 mm Drill Length
Device
EU MDR
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Eu Md Class 2a
·INTAI Technology Corp.·On the market·1 country
U2 Total Knee System Offset Stem Adapter, 2mm
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·United Orthopedic Corporation·1 device
U2 Total Knee System Offset Stem Adapter, PSA, 2mm
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·United Orthopedic Corporation·1 device
U1 Hip System Femoral Head, 28mm Dia., +0mm Neck Length
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·United Orthopedic Corporation·1 device
U1 Hip System Femoral Head, 22mm Dia., +0mm Neck Length
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·United Orthopedic Corporation·1 device
U1 Hip System Femoral Head, 36mm Dia., +0mm Neck Length
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·United Orthopedic Corporation·1 device