Home BPAP unit/BIPAP - India CDSCO Medical Device Registration
Home BPAP unit/BIPAP is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000828_eb1fca5f4e83da383b09400ce28b18c6_a0ef200465adb43e411640d3425243e0. This device is marketed under the brand name ABM. The license holder is Acer Biomedicals LLP, and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.
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Brand Name
ABM
License Holder
Acer Biomedicals LLPDevice Class
Approving Authority
Uttar Pradesh
Product Information
A portable mains electricity (ABM) device intended to assist noninvasive ventilation (ABM) using bi-level positive airway pressure (ABM) during spontaneous respiration for adult/child (ABM) patients affected by obstructive sleep apnoea (ABM), and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (ABM)]. It is a small desktop unit, which may include a built-in humidifier, intended to be used with a separate nose/mouth mask. The device is intended for use in the home but may also be used in healthcare facilities.
