Disposable vaginal speculum with zipper, 28 mm in diameter

Disposable speculum made with transparent polystyrene to provide a better view of the vaginal cavity. It has rounded edges to prevent trauma and injuries during exploration and incorporates an adjustment mechanism for the opening controlled by a zipper. The European Standard 93/42/EEC has categorized it as a class I sterile medical device and it has various ISO certifications in terms of quality and medical sterility, making it safe and reliable for cytologies and colposcopies.

Features
- Smooth finishes and atraumatic edges
- Transparent valves for better visualization of the vaginal wall
- Quick and accurate locking thanks to its adjustment system by zipper or ratchet
- Easy to handle
- Not reusable or resterilizable

Materials
- Valves: polystyrene
- Handle: polystyrene
- Zipper: polystyrene
- Free of latex and DEHP

Technical specifications
- Measure: 28 mm
- Sterilization method: ethylene oxide
- Shelf life: 5 years
- Maximum usage time: 60 minutes

Standards and certifications
- EN ISO 13485:2016
- EN ISO 14971:2012
- EN ISO 10993-1:2018
- EN ISO 10993-5:2008
- EN ISO 10993-7:2008/AC:2009
- EN ISO 10993-10:2013
- EN ISO 10993-12:2012
- EN 62366:2008
- EN ISO 11135:2014
- EN ISO 11737-1:2006/AC:2009
- EN ISO 11737-2:2009
- EN ISO 11607-1:2018
- EN ISO 11607-2:2017
- EN ISO 14644-1:2015
- EN ISO 14644-2:2015
- EN ISO 14698-1:2003
- EN ISO 14698-2:2003
- EN 556-1:2001/AC:2006
- Compliance with European Standard 93/42/EEC
- Classified as a Class I sterile medical device
- Manufactured in a clean room according to ISO Class 8
- Labeled according to EN ISO 15223-1:2016 standard