System, Thermal Regulating

FDA classification

FDA Class 2 ·System, Thermal Regulating

Controller, Temperature, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Controller, Temperature, Cardiopulmonary Bypass

Telescope, Laryngeal-Bronchial

FDA classification

FDA Class 2 ·Telescope, Laryngeal-Bronchial

Claw, Foreign Body, Bronchoscope (Non-Rigid)

FDA classification

FDA Class 2 ·Claw, Foreign Body, Bronchoscope (Non-Rigid)

Esophagoscope, Rigid, Gastro-Urology

FDA classification

FDA Class 2 ·Esophagoscope, Rigid, Gastro-Urology

335325 MDR2017B

Certificate

MDR Type Examination·Haag-Streit AG·DQS Medizinprodukte GmbH·1 Basic UDI-DI

335325 MR2

Certificate

MDD Annex II (excluding section 4)·Haag-Streit AG·DQS Medizinprodukte GmbH·19 Basic UDI-DIs

Mask, Ventilator, Non-Continuous, Reprocessed

FDA classification

FDA Class 2 ·Mask, Ventilator, Non-Continuous, Reprocessed

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

FDA classification

FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

Forceps, Biopsy, Non-Electric, Reprocessed

FDA classification

FDA Class 1 ·Forceps, Biopsy, Non-Electric, Reprocessed

HZ 1785176-1

Certificate

MDR QMS·GEOMED Medizin-Technik GmbH & Co. KG·TÜV Rheinland LGA Products GmbH

HZ 1108110-1

Certificate

MDR QMS·BEGO Implant Systems GmbH & Co. KG·TÜV Rheinland LGA Products GmbH

D130510011

Certificate

MDD Annex II (excluding section 4)·M.C. Medizintechnik-Export GmbH & Co. KG·MDC MEDICAL DEVICE CERTIFICATION GMBH·8 Basic UDI-DIs

D1305100011

Certificate

MDD Annex II (excluding section 4)·M.C. Medizintechnik-Export GmbH & Co. KG·MDC MEDICAL DEVICE CERTIFICATION GMBH·153 Basic UDI-DIs

Hofmeester Dental B.V.

Importer

🇳🇱 Netherlands·16 Manufacturers

Stabilizer, Heart, Non-Compression, Reprocessed

FDA classification

FDA Class 1 ·Stabilizer, Heart, Non-Compression, Reprocessed

Dental-Contact Vertriebs KG

Authorized representative

🇩🇪 Germany·1 Manufacturer

Bureau Medica Intercert DK

Authorized representative

🇩🇰 Denmark·2 Manufacturers

Accessories, Germicide, Cleaning, For Endoscopes

FDA classification

FDA Class 2 ·Accessories, Germicide, Cleaning, For Endoscopes

Cystoscope And Accessories, Flexible/Rigid

FDA classification

FDA Class 2 ·Cystoscope And Accessories, Flexible/Rigid