Surgical Incision Closure Set · CE MDR Class IIa
A sterile, non-invasive closure set for surgical incisions. The surgeon rotates the levers to bring the skin edges together, adjusting tension precisely. The patient can re-adjust it at home. No staples, no stitch removal, no second wound.
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BI-FIX is applied at the end of the operation, after subcutaneous layered sutures have reduced wound tension.
Subcutaneous layered sutures with incision margins no more than 8 mm apart. The skin is clean, dry and oil-free.
Select the size that matches the incision, then rotate the levers one by one to bring the skin edges together. Tension is built up gradually, not all at once.
One or two gauze pieces go on top to absorb exudate, with the dressing overlapping the device. Tension can be re-adjusted later, including by the patient at home.
The set can be cut to length and follows the contour of the skin, so it works on joints and on irregular incisions.
A controlled study of cesarean section incisions compared BI-FIX with absorbable sutures. Results favoured BI-FIX on every measured endpoint.
Study design: 72 cases treated with BI-FIX and 71 with absorbable sutures, cesarean section incisions. Healing time is reported as mean ± SD in days; pain is reported as mean ± SD. Full study documentation is available to distributors on request.
The differences that matter to a surgical department.
| Property | BI-FIX | Skin staples | Adhesive strips | Absorbable sutures |
|---|---|---|---|---|
| Pierces the skin | No | Yes | No | Yes |
| Tension adjustable after application | Yes, lever by lever | No | No | No |
| Reversible | Yes, both ends can be released | Requires removal | Not adjustable | No |
| Cut to fit unusual shapes | Yes | No | No | No |
| Usable over joints | Yes, flexible base | Limited | Limited | Yes |
| Patient can adjust at home | Yes | No | No | No |
Nine lengths cover most incisions. The set can be cut for shorter incisions, so a compact stock range covers the whole department.
| Model | Length | Model | Length |
|---|---|---|---|
| 5HWH-2A | 2 cm | 5HWH-12A | 12 cm (or 6 cm × 2) |
| 5HWH-4A | 4 cm | 5HWH-16A | 16 cm (or 8 cm × 2) |
| 5HWH-6A | 6 cm | 5HWH-20A | 20 cm (or 10 cm × 2) |
| 5HWH-8A | 8 cm | 5HWH-24A | 24 cm (or 12 cm × 2) |
| 5HWH-10A | 10 cm | Custom lengths on request | |
BI-FIX is CE marked under EU MDR 2017/745 as a Class IIa device, assessed through Annex IX by a notified body. Distributors receive the full file set for local registration.
| Classification | Class IIa, Regulation (EU) 2017/745, conformity assessment route Annex IX |
|---|---|
| Notified body | DNV GL PRESAFE AS, Veritasveien 3, N-1363 Hovik, Norway (NB 2460) |
| Declaration of conformity | Dated 11 July 2024 |
| Basic UDI-DI | 6970199416WHQ01HT |
| EU authorised representative | Llins Service & Consulting GmbH, Ludwigshafen, Germany |
Cesarean section incisions, where cosmetic outcome and early mobility both matter.
Long incisions over joints, where a flexible closure follows the movement of the limb.
Short, visible incisions where scar appearance is the priority.
Clean and clean-contaminated incisions of varying length and shape.
Procedures where the patient goes home the same day and manages the wound themselves.
Excision sites on the trunk and limbs.
Typical starting terms for a new market. Final terms depend on the sizes you need, the volume and whether you handle local registration.
| Minimum order | 1,000 pieces, mixed sizes allowed |
|---|---|
| Lead time | 15 to 25 days after deposit, subject to stock |
| Payment | 30% deposit, balance before shipment; or full prepayment for small first orders |
| Samples | Free samples, courier at buyer's cost |
| Incoterms | FOB China; CIF on request |
| Registration support | Full file set plus a Letter of Authorisation for your market |
| Marketing support | Product images, procedure video, clinical data sheet, training session for your sales team |
Prices are quoted per market and per volume band. Tell us your sizes and annual volume, and we will send a quotation valid for 30 days.