Opcom Inc. (contract manufacturer, New Taipei City, TW): 1 new FDA device listing, incl. cystoscope and accessories, flexible/rigid

Opcom Inc. (New Taipei City): 1 new FDA device listing, incl. cystoscope and accessories, flexible/rigid. Its amount of 1 is above the median of 1 (50th percentile). Dated 46 days ago, it serves as a historical benchmark. Score 55/100. 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 14 published fields of this record are shown below. Locked: 49 related TW DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentOpcom Inc.
Owner / operatorOPCOM Inc.
RoleContract manufacturer
Establishment typesManufacture Medical Device for Another Party (Contract Manufacturer)
LocationNew Taipei City, TW
New listings1
DevicesCystoscope And Accessories, Flexible/Rigid
Product codesFAJ
Device classesClass II
Medical specialtiesGastroenterology, Urology
First new listing2026-09-20
Latest new listing2026-09-20
FDA registration number3000279801
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: 2026-09-20
  • 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: Opcom Inc. and 50 TW peers

  • TW DeviceEstablishmentPulse records like this one: 50
  • Opcom Inc.'s amount: 50th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every TW peer: $10,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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55 / 100 Score

  • Contract manufacturer or sterilizer adding work.
  • Class II or III devices: QMS and regulatory demands.

What is the DeviceEstablishmentPulse record for Opcom Inc. in New Taipei City?

Opcom Inc. (New Taipei City, TW), a contract manufacturer, added 1 FDA device listing on 2026-09-20.

How does Opcom Inc. compare to other DeviceEstablishmentPulse records?

Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 46 days old; check the official source for later updates before acting.

Opcom Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Opcom Inc.New Taipei City, TW150th2026-09-20
Tecomet Inc.Wilmington, MA377th2026-10-15
Bard Shannon LimitedHumacao, PR377th2026-10-14
Orchid Orthopedic Solutions Oregon, Inc.Oregon City, OR377th2026-10-05

Related records

DeviceEstablishmentPulse: Contract manufacturer 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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