Shotley Limited (foreign exporter, Kowloon, HK): 1 new FDA device listing, incl. lenses, soft contact, extended wear
Shotley Limited (Kowloon): 1 new FDA device listing, incl. lenses, soft contact, extended wear. Its amount of 1 is above the median of 2 (50th percentile). Dated 37 days ago, it serves as a historical benchmark. Score 50/100. As of 2026-11-04, 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: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 33 related HK DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Shotley Limited |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Kowloon, HK |
| New listings | 1 |
| Devices | Lenses, Soft Contact, Extended Wear |
| Product codes | LPM |
| Device classes | Class III |
| Medical specialties | Ophthalmic |
| Brand names | PureVision2 |
| First new listing | 2026-09-29 |
| Latest new listing | 2026-09-29 |
| FDA registration number | 3011521050 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (34 HK records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-29
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (HK first): Soher Med Limited (foreign exporter, Hong Kong, HK) · Soher Med Limited (foreign exporter, Hong Kong, HK) · Worldwide Supplies Limited (foreign exporter, Hong Kong, HK) · Worldwide Supplies Limited (foreign exporter, Hong Kong, HK) · Yizur Ltd (foreign exporter, Hong Kong, HK) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Shotley Limited and 34 HK peers
- HK DeviceEstablishmentPulse records like this one: 34
- Shotley Limited's amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every HK peer: $6,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
50 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Shotley Limited in Kowloon?
Shotley Limited (Kowloon, HK), a foreign exporter, added 1 FDA device listing on 2026-09-29.
How does Shotley Limited compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 37 days old, still within a typical 45-day follow-up window.
Shotley Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Shotley Limited | Kowloon, HK | 1 | 50th | 2026-09-29 |
| Cbr Enterprise Limited | Hong Kong, HK | 59 | 99th | 2026-10-23 |
| Worldwide Supplies Limited | Hong Kong, HK | 117 | 99th | 2026-10-16 |
| Worldwide Supplies Limited | Hong Kong, HK | 120 | 99th | 2026-10-19 |
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.