Non-Invasive Ventilator

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·37 devices

Sleep Apnea Therapy Device

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·15 devices

Zip 4 Surgical Skin Closure Device

FDA UDI

ZIPLINE MEDICAL, INC.·00853114007003·Zip 4 Surgical Skin Closure Device, BSC

Zip 24 Surgical Skin Closure Device

FDA UDI

ZIPLINE MEDICAL, INC.·00853114007034·Zip 24 Surgical Skin Closure Device, BSC

BCW Spirits GmbH

Importer

🇩🇪 Germany

PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

LOWE KLEARWAY

FDA 510(k)

FDA Class 2 ·Dental

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTHROBOT 100 UPPER LIMB POSITIONER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ARTHROTRACT UPPER LIMB TRACTION ACCESSORY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ARTHROBOT(TM) WRIST HOLDER ACCESSORY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ADEPT INSTRUMENT POSITIONING ACCESSORY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADEPT ENDOSCOPIC POSITIONER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ARTHROBOT BI-FOLD DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

2017-MDD/QS-044/C, 2017-MDD/DE-045/C

Certificate

MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·35 Basic UDI-DIs

2023-MDR/QS-004

Certificate

MDR QMS·BNC KOREA, Inc.·3EC International a.s.

2021-MDD/QS-023, 2021-MDD/DE-024

Certificate

MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·25 Basic UDI-DIs