Data / Medical devices / United Kingdom / Haemoband Surgical Ltd
Haemoband Surgical Ltd: FDA-registered device maker in Belfast Northern Ireland, United Kingdom, 2 510(k) clearances
Haemoband Surgical Ltd is registered with the FDA (registration 3007388124) in Belfast Northern Ireland, United Kingdom. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007388124
- Address
- The Mount Conference Centre 2 Woodstock Link, Belfast Northern Ireland, United Kingdom, BT6 8DD
- Owner or operator
- Haemoband Surgical Ltd (10031121)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 22, 2009
- Registered through
- 2026
- Brand names listed
- Haemoband-PLUS Band Ligator, SleeveLUX 16 Anoscope/Proctoscope, SleeveLUX 24 Anoscope/Proctoscope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anoscope And Accessories | FER | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Endoscope, Ac-Powered And Accessories | GCP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2025 | K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | FER | Substantially Equivalent | Haemoband Surgical, Ltd. | accessdata.fda.gov |
| July 28, 2009 | K091519 | HAEMOBAND MULTI-LIGATOR | FHN | Substantially Equivalent | Haemoband Surgical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ligator, Hemorrhoidal
- All makers of Anoscope And Accessories
- All makers of Endoscope, Ac-Powered And Accessories
Updated October 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.