FDA Device Establishments · JSON-LD · Markdown

BLUEPOINT MEDICAL GMBH & CO. KG

FEI 3012834717 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active

FEI Number3012834717
Owner / OperatorBluepoint Medical GmbH & Co. KG (#10054095)
AddressAn der Trave 15, Selmsdorf Mecklenburg-Western Pomerania, 23923, DE
Mandatory US AgentImagenix, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)DQA
Regulation § (21 CFR)870.2700
Proprietary namesNELLCOR FLEXMAX-P-HC Flexible SpO2 Sensor, Reusable, Homecare, Small; NELLCOR FLEXMAX Flexible SpO2 Sensor, Reusable; NELLCOR FLEXMAX-HC Flexible SpO2 Sensor, Reusable, Homecare; NELLCOR FLEXMAX-P Flexible SpO2 Sensor, Reusable, Small

External sources

Source: openFDA. Public-domain (CC0).