CE Marked medical device: Microdot Droplet pen needles (including 4mm/32G) listed as CE Marked in UK Drug Tariff Part IX (Appliances).
EU Declaration of Conformity issued by HTL Strefa S.A. for sterile, single Use pen needles and safety pen needles, explicitly including microdot droplet 0.23 mm x 4 mm (32G x 5/32”).
Conforms to ISO 11608 2 (needle Based injection systems for medical use – needles) and ISO 9626 (stainless steel needle tubing for the manufacture of medical devices), as stated by multiple distributors.
CE Marked medical device: Microdot Droplet pen needles (including 4mm/32G) listed as CE Marked in UK Drug Tariff Part IX (Appliances).
EU Declaration of Conformity issued by HTL Strefa S.A. for sterile, single Use pen needles and safety pen needles, explicitly including microdot droplet 0.23 mm x 4 mm (32G x 5/32”).
Conforms to ISO 11608 2 (needle Based injection systems for medical use – needles) and ISO 9626 (stainless steel needle tubing for the manufacture of medical devices), as stated by multiple distributors.
Listed in UK Drug Tariff Part IXA as an approved hypodermic appliance (Microdot Droplet 4mm/32 gauge pack of 100).
Description
Microdot Droplet Pen Needles 32G x 4mm are single-use, sterile insulin pen needles designed to provide accurate, comfortable subcutaneous injection of insulin and other injectable diabetes medications. Each needle is manufactured from thin-walled stainless steel with a tri-bevelled, silicone-coated (hypoallergenic) tip to minimise penetration force and reduce pain. The 32-gauge (approximately 0.23 mm) diameter and 4 mm length are intended to support safe, shallow injections into the subcutaneous tissue when used with an appropriate pen device and correct technique. The needles comply with ISO 11608-2 and ISO 9626 standards and are universally compatible with all major insulin pen brands and pen injector devices authorised for use with standard pen needles. They are supplied in boxes of 100 individually sterile needles for routine daily use in diabetes care.
Bnefits
Extra-sharp, tri-bevelled tip designed to reduce penetration force and make injections as pain-free as possible.
Thin-walled stainless steel construction allows improved flow and requires less extrusion force during injection.
Silicone-coated (hypoallergenic) needle surface enhances glide through the skin and maximises patient comfort.
Short 4 mm length with 32G diameter supports shallow subcutaneous injections and may help reduce the risk of intramuscular injection when used correctly.
Universally compatible with all major insulin pen devices, simplifying prescribing and stock management.
Complies with ISO 11608-2 and ISO 9626 standards for pen needles and needle tubing, indicating adherence to international performance and safety requirements.
Individually sterile-packed and single-use, helping to minimise infection risk when used with appropriate sharps handling.
Indications
Subcutaneous injection of insulin for the treatment and management of diabetes using compatible pen injector devices.
Subcutaneous injection of other licensed injectable diabetes or metabolic agents supplied in pen form (e.g. GLP-1 receptor agonists) where 32G x 4 mm pen needles are clinically appropriate.
Use in adults and children where short pen needles are recommended by diabetes guidelines and healthcare professionals to support safe injection technique.
Listed in UK Drug Tariff Part IXA as an approved hypodermic appliance (Microdot Droplet 4mm/32 gauge pack of 100).
Insulin pen needles
General use as a sterile pen needle with compatible pen injectors for subcutaneous administration of drugs, in line with device and drug prescribing information.
Composition
Thin-walled stainless steel hypodermic needle.
Nominal needle size: 32G x 4 mm (approx. 0.23 mm diameter x 4 mm length).
Tri-bevelled, precision-engineered tip.
Silicone (hypoallergenic) coating on the needle for improved comfort.
Standard pen needle hub compatible with major insulin and drug pen injector devices.
Sterile, single-use, non-pyrogenic medical device.
Typical identifiers: PIP code 3846177; EAN 5907996090273 (or related HTL-Strefa basic UDI for 0.23 mm x 4 mm / 32G x 5/32" configuration).
Formulation
Medical device only – contains no medicinal product or active pharmaceutical ingredient.
Supplied as sterile pen needles intended for use with separate insulin or drug-containing pen cartridges.
Device classification: single-use, sterile pen needle for subcutaneous injection via compatible pen injector devices.
Designed for use by patients or caregivers following training and guidance from a healthcare professional.
Packaging
Box of 100 Microdot Droplet 32G x 4mm pen needles.
Each needle individually sterile-packed in a peel-off blister or equivalent primary packaging.
Outer carton printed with product name, size (32G x 4mm), quantity, brand (Microdot Droplet) and regulatory markings (including CE mark and relevant device codes).
Intended for retail pharmacy and clinical distribution within the UK and EU markets.
Usage
Use only with compatible pen injector devices approved for subcutaneous injection of insulin or other prescribed drugs.
Before use, check that the outer packaging and individual needle blister are intact; do not use if packaging is damaged or previously opened.
Attach the needle firmly to the pen device following the pen manufacturer’s instructions, remove the protective caps, and perform any necessary priming according to the drug and pen device guidance.
Inject into recommended subcutaneous sites (such as abdomen, thigh, or upper arm) using a technique and injection angle advised by a healthcare professional; a lifted skin fold may be recommended for some patients.
After injection, carefully remove the pen needle from the device and dispose of it immediately in an approved sharps container; do not reuse needles.
Follow all local clinical guidelines, diabetes care instructions and manufacturer recommendations regarding needle length, rotation of injection sites and maximum number of daily injections.
Patients should receive training from a healthcare professional on correct injection technique, safe handling and sharps disposal.
Contraindications
Do not reuse; single-use only – reuse can increase the risk of infection, dull the needle and cause tissue damage or inaccurate dosing.
Do not use if the sterile barrier is damaged or the needle appears bent or defective.
Not suitable for intramuscular or intravenous injection; indicated only for subcutaneous use with compatible pen devices.
Care should be taken in individuals with known hypersensitivity to silicone or stainless steel; alternative devices may be required where clinically indicated.
Use only with drugs and pen devices specifically approved for use with disposable pen needles and in accordance with their instructions for use.
Adverse Effects
Typical injection-site reactions, such as mild pain, redness, bruising, bleeding or local irritation, may occur.
Improper technique (e.g. incorrect angle, depth or site) can lead to lipohypertrophy, lipoatrophy or variable insulin absorption over time.
Rarely, infection or abscess formation can occur at injection sites if aseptic technique and proper site care are not maintained.
Bent or damaged needles, or reuse of needles, may increase pain, risk of needle breakage and tissue trauma.
Storage Conditions
Store in a clean, dry environment at room temperature.
Keep in original outer carton until required to help protect the individual sterile packs.
Protect from excessive heat, moisture and direct sunlight.
Keep out of reach of children and unauthorised users.
Do not use beyond the expiry date printed on the packaging.
