Carver, Wax, Dental

FDA classification

FDA Class 1 ·Carver, Wax, Dental

Laser Fax Machine

FDA classification

FDA Not Classified ·Laser Fax Machine

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

FDA classification

FDA Class 1 ·Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

FDA Pre-Market Approval

BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAX

Applicator, Rapid Wax, Dental

FDA classification

FDA Class 2 ·Applicator, Rapid Wax, Dental

GEM SRL

Manufacturer

🇮🇹 Italy·28 Basic UDI-DIs·38 Devices·TUV Rheinland Italia SRL, ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and TUV Rheinland Italia SRL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max

Flowmeter, Tube, Thorpe, Back-Pressure Compensated

FDA classification

FDA Class 1 ·Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control

PTT

Basic UDI-DI

EU IVDD · Eu Ivd General ·NS BIOTEC·1 device

Timon Ax

Authorized representative

🇩🇪 Germany

MED-RAS GmbH Regulatory Affairs Service

Authorized representative

🇩🇪 Germany·18 Manufacturers·235 Devices

ITD 2406494 1

Certificate

MDR QA·AUTEL S.r.l.·TUV Rheinland Italia SRL

ITD 1344523 1

Certificate

MDR QA·Dispotech srl·TUV Rheinland Italia SRL

DZ 2111577-1

Certificate

MDR QA·SHAOXING YIBON MEDICAL CO., LTD.·TÜV Rheinland LGA Products GmbH

CN24/00002692

Certificate

MDR QA·APT Medical Inc.·SGS Belgium NV

1434-MDR-023/2024

Certificate

MDR QA·Maximus s.c. Robert Klejdysz, Alicja Daniecka-Klejdysz·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

DZ 2081569-1

Certificate

MDR QA·CYBERDYNE Inc.·TÜV Rheinland LGA Products GmbH