CE Marked sterile, single Use safety lancet medical device marketed in the UK and EU.
Listed in the UK NHS Drug Tariff Part IXA as "Microdot SuperLite, 1.8mm/30 gauge, 200" manufactured by Cambridge Sensors Limited.
Designed to meet the requirements of EU Sharps Directive 2010/32/EU regarding prevention of sharps injuries in the healthcare sector.
CE Marked sterile, single Use safety lancet medical device marketed in the UK and EU.
Listed in the UK NHS Drug Tariff Part IXA as "Microdot SuperLite, 1.8mm/30 gauge, 200" manufactured by Cambridge Sensors Limited.
Designed to meet the requirements of EU Sharps Directive 2010/32/EU regarding prevention of sharps injuries in the healthcare sector.
Manufactured under an ISO 13485 Compliant medical device quality management system and registered with the UK MHRA as part of the Microdot safety lancet range.
Description
Microdot Superlite Safety Lancet - 30G / 1.8mm is a sterile, single-use, pressure-activated safety lancet designed for capillary blood sampling, such as blood glucose monitoring. It features a smooth, auto-polished, tri-bevel stainless-steel needle with a 30-gauge diameter and fixed penetration depth of 1.8 mm, silicone coated to maximise comfort and reduce pain. The needle is fully shielded before activation and automatically retracts and locks out after use, helping to minimise needle stick injuries, cross infection and reuse. Microdot Superlite Safety Lancets are intended to be an easy-to-use, cost-effective solution widely used in NHS and private healthcare settings and are suitable for adults and children. Packaging and Instructions for Use are provided in English, Spanish, French and German, and the device is designed to meet the EU Sharps Directive 2010/32/EU.
Bnefits
Ultra-fine 30G needle with 1.8 mm penetration depth provides virtually painless capillary blood sampling, suitable for adults and children.
Smooth, auto-polished, tri-bevel needle tip and silicone coating help reduce penetration force and maximise patient comfort.
Pressure-activated mechanism requires no arming, simplifying use and delivering a consistent puncture depth.
Single-use retractable safety lock-out feature prevents accidental needle sticks and eliminates the possibility of needle reuse.
Needle is fully shielded before and after use, improving sharps safety and infection control.
Designed as a cost-effective safety lancet, reducing wastage costs within NHS and private medical sectors.
Packaging and IFU available in English, Spanish, French and German to support multi-lingual clinical environments.
Part of a colour-coded range of Microdot safety lancets, making gauge and depth identification easier for healthcare staff.
Indications
Capillary blood sampling for self-monitoring of blood glucose in people with diabetes.
Capillary blood collection for other point-of-care tests where a small blood drop is required and a 30G / 1.8 mm lancet is appropriate.
Use in primary care, community clinics, pharmacies and hospital departments where safety-engineered lancets are preferred.
Manufactured under an ISO 13485 Compliant medical device quality management system and registered with the UK MHRA as part of the Microdot safety lancet range.
Marketed as OSHA Compliant with respect to sharps safety and personal protective equipment clauses in relevant territories.
Marketed as OSHA Compliant with respect to sharps safety and personal protective equipment clauses in relevant territories.
Pressure-activated single-use safety lancet
Home blood glucose testing, including paediatric and travel use, when safe sharps handling and ease of use are important.
Needle tip: smooth, auto-polished, tri-bevel grind for improved comfort and reliable penetration.
Penetration depth: fixed 1.8 mm.
Needle coating: silicone (hypoallergenic) to reduce friction and penetration force.
Housing: moulded plastic body that fully encloses the needle before and after use.
Internal mechanism: spring-driven, pressure-activated lancing system with automatic needle retraction and permanent lock-out.
Device characteristics: sterile, single-use, non-reusable, typically latex-free and non-pyrogenic safety lancet.
Formulation
Medical device only; contains no medicinal product or active pharmaceutical ingredient.
Pre-assembled, ready-to-use safety lancet requiring no prior loading or arming.
Designed specifically for capillary blood sampling from fingertip or other approved sites, in line with clinical protocols.
Packaging
Supplied as a box of 200 Microdot Superlite Safety Lancets (30G / 1.8mm).
Each lancet is individually sterile-packed to maintain sterility until the point of use.
Outer carton labelled with product name and variant (Microdot Superlite Safety Lancet - 30G / 1.8mm), brand (Microdot), quantity (200), SKU/PIP code (394-9641) and regulatory symbols including CE mark.
Packaging and Instructions for Use provided in English, Spanish, French and German.
Intended for distribution through pharmacies, online medical suppliers and hospital or clinic procurement channels.
Usage
For single use only; do not reuse. Dispose of the lancet immediately after use in an approved sharps container.
Verify that the individual sterile pack is intact before use; do not use if the packaging is damaged or opened.
Twist off the protective cap to arm the device; the needle remains concealed within the housing.
Place the flat end of the lancet firmly against the chosen sampling site (e.g. side of a fingertip or other approved capillary site).
Apply steady pressure to the device; the pressure-activated mechanism will deploy and retract the needle automatically, producing a controlled puncture.
Allow a blood drop to form and collect the sample according to the instructions for the test strip or point-of-care device being used.
After sampling, discard the used lancet directly into a designated sharps container; do not attempt to recap or tamper with the device.
Use only by, or under the guidance of, trained healthcare professionals or appropriately instructed patients and carers, following local guidelines on capillary blood sampling and sharps disposal.
Contraindications
Do not use if the individual sterile pack is damaged, opened or contaminated.
Not intended for venous or arterial blood sampling; for capillary blood sampling only.
Do not reuse; reuse increases the risk of infection, pain, tissue damage and device malfunction.
Use with caution, or consider alternative devices, in patients with known hypersensitivity to stainless steel or silicone.
Follow local clinical policies and professional guidance when lancing patients with bleeding disorders, on anticoagulant therapy, or with significantly impaired peripheral circulation.
Observe specific recommendations for sampling sites in neonates, infants, children and adults as per local guidelines.
Adverse Effects
Mild, transient pain or stinging at the puncture site.
Localised redness, slight bruising or a small haematoma at the sampling site.
Rare risk of local infection if skin preparation is inadequate or if post-procedure care is poor.
Repeated sampling from the same area may lead to local skin thickening or callus formation over time.
Occasional vasovagal responses (e.g. dizziness, faintness) related to blood sampling procedures in susceptible individuals.
Storage Conditions
Store in a clean, dry environment at room temperature.
Protect from excessive heat, moisture and direct sunlight.
Keep in the original outer carton until use to protect individual sterile packs and preserve labelling information.
Do not use after the expiry date printed on the packaging.
Keep out of reach of children and unauthorised users.
