60 results · 119ms · Sources: EU EUDAMED, US FDA

RXS 1000

FDA 510(k)
FDA Class 2 ·Dental

ULTRA-LITE

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Rolence Enterprise Inc.·2 devices

ELiTEDENT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Rolence Enterprise Inc.·2 devices

Portable X-Ray

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Rolence Enterprise Inc.·1 device

Intraoral Digital X-Ray Sensor

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Rolence Enterprise Inc.·1 device

ELiTEDENT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Rolence Enterprise Inc.·1 device

1434-MDD-136/2021

Certificate
MDD Annex II (excluding section 4)·Rolence Enterprise Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

1434-MDD-135/2021

Certificate
MDD Annex II (excluding section 4)·Rolence Enterprise Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·9 Basic UDI-DIs

CMC Medical Devices & Drugs SL

Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices

ULTRASONIC SCALER ELEGANCE MS-10 (25K)

FDA 510(k)
FDA Class 2 ·Dental

ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES

FDA 510(k)
FDA Class 1 ·Dental