DeviceEstablishmentPulse / report

Rejoni, Inc (manufacturer, Bedford, MA): 1 new FDA device listing, incl. barrier, absorbable, adhesion

Rejoni, Inc (Bedford, Massachusetts): 1 new FDA device listing, incl. barrier, absorbable, adhesion. Its amount of 1 is above the median of 1 (50th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 80/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median

Free preview: all 13 published fields of this record are shown below. Locked: 69 related MA DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentRejoni, Inc
RoleManufacturer
Establishment typesManufacture Medical Device
LocationBedford, MA, US
New listings1
DevicesBarrier, Absorbable, Adhesion
Product codesMCN
Device classesClass III
Brand namesJuveena Hydrogel System
First new listing2026-09-29
Latest new listing2026-09-29
FDA registration number3033307563
Registration expires2026-12-31
amount percentile50th of 2,570 (median 1, 1.0x 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: 2026-09-29
  • 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: Rejoni, Inc and 70 Massachusetts peers

  • Massachusetts DeviceEstablishmentPulse records like this one: 70
  • Rejoni, Inc's amount: 50th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Massachusetts peer: $14,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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80 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • U.S. establishment.
  • Listed in the last 45 days.

What is the DeviceEstablishmentPulse record for Rejoni, Inc in Bedford, Massachusetts?

Rejoni, Inc (Bedford, MA), a manufacturer, added 1 FDA device listing on 2026-09-29.

How does Rejoni, Inc compare to other Massachusetts DeviceEstablishmentPulse records?

Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 36 days old, still within a typical 45-day follow-up window. Its Score of 80/100 puts it among the stronger signals in this feed.

Rejoni, Inc vs. top 2 peers

OrganizationLocationAmountPercentileRecord date
Rejoni, IncBedford, MA150th2026-09-29
Beacon Biosignals, Inc.Boston, MA377th2026-10-16
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA688th2026-10-16

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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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