Oftal-One Inc (repackager or relabeler, Coral Gables, FL): 1 new FDA device listing, incl. general purpose reagent
Oftal-One Inc (Coral Gables, Florida): 1 new FDA device listing, incl. general purpose reagent. Its amount of 1 is above the median of 2 (50th percentile). Dated 72 days ago, it serves as a historical benchmark. Score 35/100. 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 13 published fields of this record are shown below. Locked: 90 related FL DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Oftal-One Inc |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Coral Gables, FL, US |
| New listings | 1 |
| Devices | General Purpose Reagent |
| Product codes | PPM |
| Device classes | Class I |
| Medical specialties | Pathology |
| First new listing | 2026-08-25 |
| Latest new listing | 2026-08-25 |
| FDA registration number | 3016248648 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (91 FL 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: 2026-08-25
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (FL first): Oketz Logistics LLC (repackager or relabeler, Coral Gables, · Oketz Logistics LLC (repackager or relabeler, Coral Gables, · Zapalign LLC (repackager or relabeler, Fort Lauderdale, FL) · Stellmacher Instruments Inc (repackager or relabeler, Orland · Surgipros LLC (repackager or relabeler, Palmetto, FL) · 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: Oftal-One Inc and 91 Florida peers
- Florida DeviceEstablishmentPulse records like this one: 91
- Oftal-One Inc's amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $18,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Score
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Oftal-One Inc in Coral Gables, Florida?
Oftal-One Inc (Coral Gables, FL), a repackager or relabeler, added 1 FDA device listing on 2026-08-25.
How does Oftal-One Inc compare to other Florida DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 72 days old; check the official source for later updates before acting. Its Score of 35/100 is modest; treat it as background rather than a priority.
Oftal-One Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Oftal-One Inc | Coral Gables, FL | 1 | 50th | 2026-08-25 |
| VIVE Health LLC | Naples, FL | 9 | 92nd | 2026-10-14 |
| Oketz Logistics LLC | Coral Gables, FL | 56 | 99th | 2026-10-12 |
| Oketz Logistics LLC | Coral Gables, FL | 62 | 99th | 2026-10-21 |
Related records
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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.