Organox Limited (repackager or relabeler, Oxford Oxfordshire, GB): 1 new FDA device listing, incl. monitor, blood-gas, on-line, cardiopulmonary bypass

Organox Limited (Oxford Oxfordshire): 1 new FDA device listing, incl. monitor, blood-gas, on-line, cardiopulmonary bypass. Its amount of 1 is above the median of 2 (50th percentile). Dated 146 days ago, it serves as a historical benchmark. Score 40/100. 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: 70 related GB DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentOrganox Limited
Owner / operatorOrganOx Limited
RoleRepackager or relabeler
Establishment typesRepack or Relabel Medical Device
LocationOxford Oxfordshire, GB
New listings1
DevicesMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Product codesDRY
Device classesClass II
Medical specialtiesCardiovascular
First new listing2026-06-12
Latest new listing2026-06-12
FDA registration number3011560054
Registration expires2027-12-31
amount percentile50th of 2,709 (median 2, 0.5x 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: 2026-06-12
  • Data refreshed: 2026-11-04
  • 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, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Organox Limited and 71 GB peers

  • GB DeviceEstablishmentPulse records like this one: 71
  • Organox Limited's amount: 50th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every GB peer: $14,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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40 / 100 Score

  • Class II or III devices: QMS and regulatory demands.

What is the DeviceEstablishmentPulse record for Organox Limited in Oxford Oxfordshire?

Organox Limited (Oxford Oxfordshire, GB), a repackager or relabeler, added 1 FDA device listing on 2026-06-12.

How does Organox 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 146 days old; check the official source for later updates before acting.

Organox Limited vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Organox LimitedOxford Oxfordshire, GB150th2026-06-12
Gurin Products LLCTustin, CA377th2026-10-22
Tpc Advanced Technology, Inc.City Industry, CA483rd2026-09-28
Uih Technologies, LLCHouston, TX890th2026-10-21

Related records

DeviceEstablishmentPulse: Repackager or relabeler DeviceEstablishmentPulse: Foreign establishment

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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

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.

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