HI (ITE)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·150 devices

G2S 056820 0038

Certificate

MDD Annex V·GRI Medical & Electronic Technology Co., Ltd.·TÜV SÜD Product Service GmbH·91 Basic UDI-DIs

G2 056820 0037

Certificate

MDD Annex V·GRI Medical & Electronic Technology Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

Semiconductor Laser Treatment Instrument

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Counter Scientific Development (GZ) Limited·1 device

Semiconductor Laser Treatment

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Counter Scientific Development (GZ) Limited·1 device

Pain Therapy Device

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Counter Scientific Development (GZ) Limited·1 device

Mask for Radiation therapy

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Klarity Medical & Equipment（GZ） Co.,Ltd.·2 devices

CN19/41136

Certificate

MDD Annex II (excluding section 4)·Counter Scientific Development (GZ) Limited·SGS Belgium NV·3 Basic UDI-DIs

SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCURIS MEDICAL SRL

Importer

🇷🇴 Romania·6 Manufacturers

Lohmann & Rauscher International GmbH & Co. KG

Importer

🇩🇪 Germany·23 Manufacturers

ProCare Ltd.

Importer

🇲🇹 Malta·24 Manufacturers

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

Lotus NL B.V.

Authorized representative

🇳🇱 Netherlands·584 Manufacturers·21427 Devices