HZ 2163352-1

Certificate

MDR QMS·BDC Dental Corporation Ltd.·TÜV Rheinland LGA Products GmbH

170771754

Certificate

MDD Annex II (excluding section 4)·BSC Medical Devices GmbH·DQS Medizinprodukte GmbH·11 Basic UDI-DIs

170770754

Certificate

MDD Annex II (excluding section 4)·BSC Medical Devices GmbH·DQS Medizinprodukte GmbH·1 Basic UDI-DI

BEC GmbH

System producer

🇩🇪 Germany

INSIGHT ELECTRONIC ALIGNMENT INDICATOR

FDA 510(k)

FDA Class 1 ·Orthopedic

INSITE FILTER & TUBING SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

INSITE MODEL 20 & MODEL 15 INSUFFLATORS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDEX ENDOSCOPIC POSITIONING SYSTEM

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330851·L-DFA Influenza A/Influenza B Reagent

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330752·D3 FASTPOINT RESP VIRUS ID KIT

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330776·D3 FASTPOINT LDFA VIR IDKIT BX

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330875·L-DFA Parainfluenza Virus/Adenovirus Reagent

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330769·D3 FASTPOINT LDFA VIR IDKIT BX

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330868·L-DFA RSV/MPV Reagent

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330844·Re-Suspension Buffer

BMC MEDICAL TRADE (FRANCE) SARL

Importer

🇫🇷 France

Needle, Emergency Airway

FDA classification

FDA Class 2 ·Needle, Emergency Airway

Bag, Reservoir

FDA classification

FDA Class 1 ·Bag, Reservoir

BZT-TCP Certification GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers