Blade, Keratome, Reprocessed

FDA classification

FDA Class 1 ·Blade, Keratome, Reprocessed

MI-NOVA 6+6, MI -NOVA6 ; MI-NOVA 5+5,MI-NOVA 5 ; MI-NOVA 4+4, MI -NOVA 4; MI-NOVA 3+3 ;MI-NOVA 6+5;

FDA registration

MORBROS INDIA·1 product·🇮🇳 India

Medicinal Non-Ventilatory Nebulizer (Atomizer) : MY-123-1; MY-125-1; MY-126-1; MY-127-1; MY-128-1; MY-129-1

FDA registration

SHENZHEN IVANKACA TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

GENNY FACTORY SA

Manufacturer

🇨🇭 Switzerland·1 Basic UDI-DI·1 Device

AMI AUTONOMIE

Manufacturer

🇫🇷 France·4 Basic UDI-DIs·4 Devices

AMI INC.

Manufacturer

🇰🇷 South Korea·28 Basic UDI-DIs·28 Devices·MTIC InterCert S.r.l. and MTIC InterCert S.r.l.

Medicina Limited

Manufacturer

1 Importer

AMI Medical Limited

Manufacturer

Lenstec (Barbados) Inc.

Manufacturer

🇧🇧 Barbados·764 Basic UDI-DIs·764 Devices·3 Importers·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Art-Emis Hamburg GmbH

Manufacturer

🇩🇪 Germany

BMI Biomedical International S.r.l.

Manufacturer

🇮🇹 Italy

BMI Korea Co., Ltd.

Manufacturer

🇰🇷 South Korea

EMI FACTORY CO., LTD.

Manufacturer

🇯🇵 Japan

ACCUNIQ BC310

FDA registration

SELVAS Healthcare, Inc.·1 product·🇰🇷 South Korea

ACCUNIQ BC300

FDA registration

SELVAS Healthcare, Inc.·1 product·🇰🇷 South Korea

ACCUNIQ BC360

FDA registration

SELVAS Healthcare, Inc.·1 product·🇰🇷 South Korea

ACCUNIQ BP250

FDA registration

SELVAS Healthcare, Inc.·1 product·🇰🇷 South Korea

A-MI GLOBAL CO., LTD.

Manufacturer

🇰🇷 South Korea

COLORMAX PLUS Q-Switched Nd:YAG Laser System

FDA registration

AMI INC.·1 product·🇰🇷 South Korea

BIOXEL Fractional CO2 Laser System

FDA registration

AMI INC.·1 product·🇰🇷 South Korea