FUJIFILM Healthcare Americas Corporation (repackager or relabeler, Edison, NJ): 9 new FDA device listings, incl. titrimetric, fatty acids

FUJIFILM Healthcare Americas Corporation (Edison, New Jersey): 9 new FDA device listings, incl. titrimetric, fatty acids. Its amount of 9 is top-decile (92nd percentile of 2,709 records). Dated 57 days ago, it serves as a historical benchmark. Score 65/100. 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: 9 · 92th percentile of 2,709 DeviceEstablishmentPulse records · 4.5x the median

Free preview: all 15 published fields of this record are shown below. Locked: 49 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentFUJIFILM Healthcare Americas Corporation
Owner / operatorFujifilm Corporation
RoleRepackager or relabeler
Establishment typesRepack or Relabel Medical Device
LocationEdison, NJ, US
New listings9
DevicesTitrimetric, Fatty Acids; System, Test, Low Density, Lipoprotein; Calibrator, Primary; Ldl & Vldl Precipitation, Hdl; Complement C9, Antigen, Antiserum, Control; Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.); Single (Specified) Analyte Controls (Assayed And Unassayed)
Product codesJLH, MRR, JIS, LBR, DAE, JIQ, JJX
Device classesClass I, Class II
Medical specialtiesClinical Chemistry, Immunology
Brand namesHR SERIES NEFA-HR2 Solvent A; HR SERIES NEFA-HR2 Color Reagent A; HR SERIES NEFA-HR2 Solvent B; HR SERIES NEFA-HR2 Color Reagent B; L-Type LDL-C Reagent; L-Type HDL-C Reagent; CH50 Calibrator; AUTOKIT CH50
First new listing2026-09-09
Latest new listing2026-09-09
FDA registration number3005625991
Registration expires2026-12-31
amount percentile92th of 2,709 (median 2, 4.5x 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: 2026-09-09
  • 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: FUJIFILM Healthcare Americas Corporation and 50 New Jersey peers

  • New Jersey DeviceEstablishmentPulse records like this one: 50
  • FUJIFILM Healthcare Americas Corporation's amount: 92nd percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every New Jersey peer: $10,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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65 / 100 Score

  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for FUJIFILM Healthcare Americas Corporation in Edison, New Jersey?

FUJIFILM Healthcare Americas Corporation (Edison, NJ), a repackager or relabeler, added 9 FDA device listings on 2026-09-09.

How does FUJIFILM Healthcare Americas Corporation compare to other New Jersey DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 9 is 4.5x the median of 2 across 2,709 records. It is 57 days old; check the official source for later updates before acting.

FUJIFILM Healthcare Americas Corporation vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
FUJIFILM Healthcare Americas CorporationEdison, NJ992nd2026-09-09
VIVE Health LLCNaples, FL992nd2026-10-14
Uih Technologies, LLCHouston, TX890th2026-10-21
Tpc Advanced Technology, Inc.City Industry, CA483rd2026-09-28

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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.

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