Instraspec Contour is an award-winning, safe, unbreakable plastic single-use speculum that also delivers exceptional value for money.
Gynaecological examinations and procedures can often be daunting for patients. Both patients and clinican require a vaginal speculum that is safe and comfortable with no risk of cross infection. Instraspec Contour® addresses these needs and more thanks to thoughtful design and the use of advanced materials in its manufacture.
Confidence and Comfort
- Class IIa medical device - audited by our notified body
- Unbreakable - SMTL 3rd party tested
- Single-use medical device - no cross-contamination
- Prestigious Red Dot Award winner
- Anti-pinch beak profile
- Gel pockets for enhanced lubrication retention
- Guided nut and runner for silent and smooth operation
- Available in a range of sizes to suit the patient
- Latex free
Compliance with Legislation & Standards
It is a legal requirement for all medical devices to comply with the Medical Devices Directive (MDD) 93/42 EEC and carry the CE mark. Regulatory requirements differ according to the risk attached to the use of the product. The lower the risk, the easier it is to comply with the Directive.
Single-use instruments are relatively high risk as many are surgically invasive and therefore classified as lla devices. They are therefore subject to greater levels of control than reusables, which are Class l devices except those used on central nervous tissue. Class l devices can be sold without any authorisation from an independent third party - a Notified Body. Class lla devices require a Notified Body to assess the production of the device to Annex lV, V or Vl of the Directive and issue a certificate of conformance before a CE mark can be applied and the product legally sold.
Certification by the British Standards Institution (BSI) verifies that Instraspec Contour® products meet fully the requirements of the Regulation.
Want to learn more about Instraspec Contour®?
Come and talk to us.
We have a team of specialists available if you want to know more about the features and benefits of Instraspec Contour®.