CE Marked sterile, single Use safety lancet marketed in the UK/EU as a medical device.
Designed to meet the requirements of EU Sharps Directive 2010/32/EU regarding prevention of sharps injuries in the healthcare sector.
Conforms to general safety and performance requirements for needle Based single Use medical devices as described in manufacturer documentation.
CE Marked sterile, single Use safety lancet marketed in the UK/EU as a medical device.
Designed to meet the requirements of EU Sharps Directive 2010/32/EU regarding prevention of sharps injuries in the healthcare sector.
Conforms to general safety and performance requirements for needle Based single Use medical devices as described in manufacturer documentation.
Pressure-activated single-use safety lancet
Description
Microdot Lite Safety Lancet - 28G / 1.8mm is a sterile, single-use, pressure-activated safety lancet specifically designed for capillary blood sampling, such as blood glucose and HbA1c testing. It incorporates a smooth, auto-polished, tri-bevel stainless-steel needle (28 gauge) with a fixed penetration depth of 1.8 mm and a silicone (hypoallergenic) coating to maximise comfort and reduce pain. The needle is fully shielded before activation and automatically retracts and locks out immediately after use, helping to prevent needle stick injuries, cross infection and reuse. Microdot Safety Lancets are presented as a cost-effective solution for NHS and private healthcare providers, meeting EU Sharps Directive 2010/32/EU requirements and supplied in multilingual packaging (English, Spanish, French and German). Boxes typically contain 200 individually sterile lancets, with PIP code 394-9633 for the Lite 28G / 1.8mm variant.
Bnefits
Smooth, auto-polished, tri-bevel 28G needle designed to maximise comfort and reduce pain during capillary blood sampling.
Pressure-activated mechanism (no button) for simple, intuitive use and consistent penetration depth of 1.8 mm.
Single-use retractable safety lock-out feature prevents accidental needle sticks and eliminates the risk of needle reuse.
Needle is fully covered before and after use, improving safety and infection control for patients and healthcare workers.
Sterile, single-use design that helps minimise cross infection and disposal issues compared with reusable lancing devices.
Cost-effective safety lancet widely used within NHS and private medical sectors, helping reduce wastage and misfire-related costs.
Packaging and IFU in English, Spanish, French and German to support use across multiple countries.
Designed to meet EU Sharps Directive 2010/32/EU, supporting compliance with occupational safety legislation.
Indications
Capillary blood sampling for blood glucose monitoring in people with diabetes.
Capillary blood sampling for HbA1c and other point-of-care tests where a 28G / 1.8 mm lancet is appropriate.
Use in clinical environments (hospitals, GP practices, clinics, community care) where safety lancets are required to minimise sharps injuries.
Needle surface: silicone coated (hypoallergenic) to reduce penetration force and improve comfort.
Housing: pre-assembled plastic body with integrated spring-driven, pressure-activated mechanism.
Internal spring and lock-out system allowing single activation and automatic needle retraction after use.
Sterile, single-use device supplied non-pyrogenic and latex-free (as per Microdot safety lancet range specifications).
Formulation
Medical device only – no medicinal product or active pharmaceutical ingredient included.
Pre-assembled, ready-to-use safety lancet with internal spring mechanism and concealed needle.
Designed as a sterile, single-use capillary sampling device for professional or trained patient use.
Packaging
Supplied typically as a box of 200 Microdot Lite Safety Lancets (28G / 1.8mm).
Each lancet is individually sterile-packed to maintain sterility until point of use.
Outer carton printed with product variant (Lite 28G / 1.8mm), quantity, PIP code 394-9633, Microdot branding and regulatory markings (including CE mark in applicable markets).
Packaging and Instructions for Use provided in English, Spanish, French and German.
Usage
Single use only – do not reuse. Dispose of each lancet immediately after use in an approved sharps container.
Check that the individual lancet packaging is intact before use; do not use if packaging is damaged or opened.
Twist off the protective cap to arm the device and expose the internal mechanism (needle remains concealed).
Place the flat end of the lancet firmly against the chosen lancing site (e.g., side of the fingertip or alternative approved site).
Apply pressure to the device against the skin; the pressure-activated mechanism will deploy and retract the needle automatically.
Collect the blood sample according to the instructions for the test strip or point-of-care device being used.
After sampling, dispose of the used lancet immediately in a designated sharps container according to local clinical waste policies.
Use only by, or under the training/guidance of, healthcare professionals or appropriately instructed patients/carers.
Contraindications
Do not use if the sterile barrier or individual lancet packaging is damaged or previously opened.
Not intended for venous or arterial blood sampling; for capillary sampling only.
Do not reuse; reuse of a safety lancet increases the risk of infection, tissue damage and device malfunction.
Use with caution, or consider alternative devices, in individuals with known hypersensitivity to stainless steel or silicone coatings.
Follow professional guidance and local policies for lancing in patients with poor peripheral circulation, bleeding disorders or on anticoagulant therapy.
Adverse Effects
Mild, transient pain or discomfort at the lancing site.
Localised redness, small haematoma or bruising at the puncture site.
Rare risk of infection at the lancing site if skin preparation or aftercare is inadequate.
In very rare cases, local irritation or hypersensitivity reaction related to device materials may occur.
Storage Conditions
Store in a clean, dry environment at room temperature.
Keep away from excessive heat, moisture and direct sunlight.
Keep in original outer carton until use to protect individual sterile packs.
Do not use beyond the expiry date printed on the packaging.
Keep out of reach of children and unauthorised users.
