Disposable vaginal speculum with zipper, 16mm in diameter

Disposable vaginal speculum designed with smooth edges in order to provide a non-traumatic gynecological examination experience. It has a zipper that allows one-handed adjustment and is made from transparent polystyrene for greater visibility of the vaginal walls. It is classified as a class Is medical device and has multiple ISO certifications, making it safe and reliable for colposcopies and cytologies.

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

Materials
- Valves: polystyrene
- Handle: polystyrene
- Zipper: polystyrene
- Latex and DEHP free

Technical specifications
- Size: 16 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 Regulation 93/42/EEC
- Classified as a Class I sterile medical device
- Manufactured in a clean room according to ISO Class 8
- Labeling according to EN ISO 15223-1:2016 standard