Reference. 9QVSST28 [FA]
Savings format
Disposable vaginal speculum with zipper, 28 mm in diameter
Disposable 28-millimeter diameter gynecological speculum equipped with a zip regulation system for the opening. Categorized as Class Is medical device and certified by multiple ISO standards.
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Description
Disposable speculum made of transparent polystyrene to provide a better view of the vaginal cavity. It has rounded edges to avoid trauma and injuries during the examination and incorporates an adjustable opening mechanism regulated by a zipper. The European Regulation 93/42/EEC has categorized it as a Class I sterile medical product and it has various ISO certifications in terms of quality and medical sterility, so it is safe and reliable for cytologies and colposcopies.
Features
- Smooth finishes and atraumatic edges
- Transparent valves for a better visualization of the vaginal wall
- Quick and precise locking thanks to its adjustment system by zipper or ratchet
- Easy manipulation
- Not reusable or resterilizable
Materials
- Valves: polystyrene
- Handle: polystyrene
- Zipper: polystyrene
- Latex and DEHP free
Technical specifications
- Size: 28 mm
- Sterilization method: ethylene oxide
- Shelf life: 5 years
- Maximum use 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 product
- Manufactured in a clean room according to ISO Class 8
- Labeling according to EN ISO 15223-1:2016 standard
Supplied in a box of 100 units.
Features
- Smooth finishes and atraumatic edges
- Transparent valves for a better visualization of the vaginal wall
- Quick and precise locking thanks to its adjustment system by zipper or ratchet
- Easy manipulation
- Not reusable or resterilizable
Materials
- Valves: polystyrene
- Handle: polystyrene
- Zipper: polystyrene
- Latex and DEHP free
Technical specifications
- Size: 28 mm
- Sterilization method: ethylene oxide
- Shelf life: 5 years
- Maximum use 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 product
- Manufactured in a clean room according to ISO Class 8
- Labeling according to EN ISO 15223-1:2016 standard
Supplied in a box of 100 units.


