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Flat Medical Co., Ltd.

Manufacturer
🇹🇼 Taiwan·4 Basic UDI-DIs·4 Devices·2 Importers·BSI Group The Netherlands B.V.

FLAT MEDICAL CO., LTD.

FDA registration
FLAT MEDICAL CO., LTD.·2 products·🇹🇼 Taiwan

EpiFaith CV

FDA UDI
Flat Medical Co., Ltd.·04719875599033·The EpiFaith CV is intended for use in central ...

EpiFaith Syringe

FDA UDI
Flat Medical Co., Ltd.·04719875599019·EpiFaith Syringe is intended for use with an ep...

EpiFaith Syringe

FDA UDI
Flat Medical Co., Ltd.·04719875599026·EpiFaith Syringe is intended for use with an ep...

EpiFaith Syringe

FDA UDI
Flat Medical Co., Ltd.·04719875599064·EpiFaith Syringe is intended for use with an ep...

EpiFaith Syringe

Device
EU MDR · Eu Md Class 1 ·Flat Medical Co., Ltd.·On the market

EpiFaith Syringe

Device
EU MDD · Eu Md Class 1 ·Flat Medical Co., Ltd.·On the market

EpiFaith Syringe

Device
EU MDD · Eu Md Class 1 ·Flat Medical Co., Ltd.·On the market

EpiFaith CV

Device
EU MDR · Eu Md Class 1 ·Flat Medical Co., Ltd.·On the market

ASAHI SION

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 22, 2023

ALPHA TRANCELL DELUXE

FDA Adverse Event
Death ·ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB·Product code FNM·February 18, 2017

ASTATO XS 40

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 26, 2024

ZIZAI

FDA Adverse Event
Malfunction ·TERUMO CLINICAL SUPPLY CO., LTD.·Product code DQO·November 15, 2024

CROSSLEAD PENETRATION

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·February 9, 2025

EpiFaith Syringe

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Flat Medical Co., Ltd.·1 device

EpiFaith CV

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Flat Medical Co., Ltd.·1 device

EpiFaith Syringe

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Flat Medical Co., Ltd.·1 device

EpiFaith Syringe

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Flat Medical Co., Ltd.·1 device

CE 689414

Certificate
MDD Annex II (excluding section 4)·Flat Medical Co., Ltd.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs