Optikal (Southgate) Ltd (foreign exporter, Borehamwood, GB): 3 new FDA device listings, incl. lenses, soft contact, extended wear
Optikal (Southgate) Ltd (Borehamwood): 3 new FDA device listings, incl. lenses, soft contact, extended wear. Its amount of 3 is above the median of 1 (77th percentile). Dated 22 days ago, it is in the active follow-up window. Score 65/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 65 related GB DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Optikal (Southgate) Ltd |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Borehamwood, GB |
| New listings | 3 |
| Devices | Lenses, Soft Contact, Extended Wear; Lens, Contact, (Disposable); Lenses, Soft Contact, Daily Wear |
| Product codes | LPM, MVN, LPL |
| Device classes | Class II, Class III |
| Medical specialties | Ophthalmic |
| Brand names | Air optix Night and day lotrafilconB; Avaira Vitality (6 Pack) |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-10-13 |
| FDA registration number | 3044710860 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-13
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Optikal (Southgate) Ltd and 66 GB peers
- GB DeviceEstablishmentPulse records like this one: 66
- Optikal (Southgate) Ltd's amount: 77th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every GB peer: $13,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Optikal (Southgate) Ltd in Borehamwood?
Optikal (Southgate) Ltd (Borehamwood, GB), a foreign exporter, added 3 FDA device listings between 2026-08-17 and 2026-10-13.
How does Optikal (Southgate) Ltd compare to other DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 22 days old, still within a typical 45-day follow-up window.
Optikal (Southgate) Ltd vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Optikal (Southgate) Ltd | Borehamwood, GB | 3 | 77th | 2026-10-13 | This record |
| Loudwater Trade Finance Ltd | LONDON England, GB | 3 | 77th | 2026-10-09 | Compare Optikal (Southgate) Ltd vs Loudwater Trade Finance Ltd → |
| Ad Supply Group Limited | London London, City of, GB | 39 | 99th | 2026-10-13 | View record → |
Related records
DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.