SEMM Specula 100mm/25-30 mm

SEMM SPECULUM • 100mm/25-30mm • CE-CLASS I • ISO 13485:2016

Variable Wide Speculum for Operative Gynecological Procedures

The SEMM Speculum (100mm/25-30mm) is a medical device of CE class I according to ISO 13485:2016. The variable wide speculum with extended adjustment range was specifically developed for operative gynecological procedures and situations requiring extended space.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Variable wide design 100mm/25-30mm – for surgical procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Extended adjustment range – 25-30mm flexible width adaptation
✔ Reinforced construction – for maximum stability
✔ Wide atraumatic blades – for optimal visibility
✔ Industrial adjustment mechanism – reliable locking
✔ Robust handles – for fatigue-free operation
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the SEMM Speculum 100mm/25-30mm:

• Variable wide design for optimal surgical visibility
• Flexible adjustment range for different anatomical conditions
• Reinforced construction for highest stability during procedures
• Ideal for surgical procedures and larger instrumentation
• Maximum adaptability during complex interventions

Fields of Application:

• Operative gynecological procedures
• Extended colposcopic procedures
• Therapeutic procedures under visual control
• Removal of polyps and pathologies
• Complex biopsy sampling
• Urogynecological surgeries
• Teaching and surgical training

Technical Specifications:

• Model: SEMM Speculum variable wide model
• Dimensions: 100mm length, 25-30mm variable width
• Maximum opening width: 45mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Industrial adjustment mechanism
• Adjustment range: 25-30mm width
• Blade shape: Wide, reinforced, atraumatic
• Surface: High-gloss polished, satin finish
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C
• Weight: 350g

Important Safety Information:
• For professionals experienced in operative gynecology only
• Special care required during positioning
• Check adjustment mechanism before each use
• Specifically for multiparous patients or special indications
• Regular maintenance of adjustment mechanism required