PolySuture Indústria e Comércio Ltda.

Certificate Status  Valid
Certificate No EUCE1202DE81BR
Company Name PolySuture Indústria e Comércio Ltda.
Issue Date 18 July, 2021
Validity Date 17 July, 2026
Scope Polyglactin 910 Synthetic Absorbable Surgical Suture.
Supplementary Information to CE 649012

Needle and Suture Combinations from within the following limits:
Suture Characteristics and its Range:
1. Absorbable / Non-Absorbable: Absorbable
2. Suture Gauge Size: 0.5- 6.0 (Metric)
3. Suture Length: 45 cm – 150 cm
4. Suture Dyed / Undyed: Dyed / Undyed
5. Suture Color (If Dyed): Violet / Undyed
6. Coated / Uncoated: Poly (D,L -lactide-co-glycolide) (30/70) and Calcium Stearate)
7. Multifilament / Monofilament: Multifilament
8. Accessories of Suture: N/A
9. Needled / Non-Needled: Needled / Non-Needled
10. Number of Needles per Suture: 1 – 2
11. Needle Material: Stainless Steel
12. Needle Coating: Silicon (when applicable)
13. Needle Type: Taper Point, Tapercut, Reverse Cutting, Blunt Point, Spatula, Taper Point Square Body
14. Needle Shape: Straight, 3/8 Circle, 1/2 Circle, 5/8 Circle, 1/6 Circle, 1/4 Circle
15. Needle Length: 6.5mm – 6.5cm
16. Needle Diameter: 0.140mm – 1.270 mm

Certificate Type CE – (EU) Directive 93/42/EEC on Medical Devices