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HSA · registration DE0509025

BD Ultra-Fine™ Pen Needles

SingaporeGeneral HospitalClass BBecton, Dickinson and Company
Official record identity
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
Classification
Risk class
Class B
Official value: CLASS B
Published category
General Hospital
Published parties
Registrant / registration holder
EMBECTA SINGAPORE PTE. LTD.
Official description

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

Additional source fields
Product owner address
1 Becton Drive, Franklin Lakes, NJ 07417, United States
Registrant address
300 BEACH ROAD, #19-05/07, THE CONCOURSE, Singapore 199555
About this record

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.