LiNA PowerBlade Plus HC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LINA POWERBLADE PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LINA XCISE MODEL MOR-1515

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LiNA OperaScope Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LINA-BAG, MODELS LB-60, LB-100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LiNA Versascope Outflow Cannula

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LiNA Medical ApS·1 device

LiNA Versascope Sheath

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LiNA Medical ApS·1 device

LiNA SeaStar

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LiNA Medical ApS·5 devices

LiNA LapGuard

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LiNA Medical ApS·1 device

Dia-Stop Armlet

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LiNA Medical ApS·1 device

TNP/MDR/0013/5613/2023

Certificate

MDR QMS·LiNA Medical ApS·TUV NORD Polska Sp. z o.o

LiNA Medical Polska Sp. z o.o.

Authorized representative

🇵🇱 Poland·1 Manufacturer

Cadwell Europe GmbH

Importer

🇩🇪 Germany·5 Manufacturers

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

MedEnvoy Global BV

Importer

🇳🇱 Netherlands·234 Manufacturers