BD Ultra-Fine™ Pen Needles
- Registration number
- DE0509025
- Model name
- BD Ultra-Fine™ Pen Needles 32G X 4mm - EasyFlow™ Technology/PentaPoint Comfort™; BD Ultra-Fine™ Pen Needles 32G X 4mm; BD Ultra-Fine™ Pen Needles 32G X 4mm - Pentapoint™ Comfort; BD Ultra-Fine™ Micro Pen Needles 32G X 6mm
- Model identifier
- 320405; 320475; 320476; 320749
- Registration date
- March 05, 2024
- Risk class
- Class B
- Product owner
- Becton, Dickinson and Company
- Registrant / registration holder
- EMBECTA SINGAPORE PTE. LTD.
BD Pen Needles are sterile, single-use devices intended for use with pen injectors for subcutaneous injection of drugs. Users may include caregivers, laypersons, and in countries where it is not precluded, health care professionals. The first and major application for BD pen needles is the subcutaneous administration of insulin and GLP-1 agonists for treatment of diabetes. The needles are also used to inject other medications for osteoporosis, fertility, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and plaque psoriasis and growth hormone
- Product owner address
- 1 Becton Drive, Franklin Lakes, NJ 07417, United States
- Registrant address
- 300 BEACH ROAD, #19-05/07, THE CONCOURSE, Singapore 199555
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.