Sterigenics Shanghai E Beam Ltd. (contract sterilizer, Shanghai, CN): 2 new FDA device listings, incl. catheter, straight

Sterigenics Shanghai E Beam Ltd. (Shanghai): 2 new FDA device listings, incl. catheter, straight. Its amount of 2 is above the median of 2 (69th percentile). Dated 50 days ago, it serves as a historical benchmark. Score 55/100. 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: 2 · 69th percentile of 2,709 DeviceEstablishmentPulse records · 1.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSterigenics Shanghai E Beam Ltd.
Owner / operatorSotera Health LLC
RoleContract sterilizer
Establishment typesSterilize Medical Device for Another Party (Contract Sterilizer)
LocationShanghai, CN
New listings2
DevicesCatheter, Straight; Agent, Absorbable Hemostatic, Non-Collagen Based
Product codesEZD, LMG
Device classesClass II, Class III
Medical specialtiesGastroenterology, Urology, General, Plastic Surgery
Brand namesPerClot® Polysaccharide Hemostatic System
First new listing2026-08-19
Latest new listing2026-09-16
FDA registration number3008132411
Registration expires2026-12-31
amount percentile69th of 2,709 (median 2, 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: 2026-09-16
  • Data refreshed: 2026-11-04
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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: Sterigenics Shanghai E Beam Ltd. and 720 CN peers

  • CN DeviceEstablishmentPulse records like this one: 720
  • Sterigenics Shanghai E Beam Ltd.'s amount: 69th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every CN peer: $144,000 (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 Sterigenics Shanghai E Beam Ltd. in Shanghai?

Sterigenics Shanghai E Beam Ltd. (Shanghai, CN), a contract sterilizer, added 2 FDA device listings between 2026-08-19 and 2026-09-16.

How does Sterigenics Shanghai E Beam Ltd. compare to other DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,709 records; the median is 2. It is 50 days old; check the official source for later updates before acting.

Sterigenics Shanghai E Beam Ltd. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Sterigenics Shanghai E Beam Ltd.Shanghai, CN269th2026-09-16
Isomedix Operations Inc.San Diego, CA483rd2026-10-23
Isomedix Operations, IncOntario, CA790th2026-10-15
Isomedix Operations, Inc.Libertyville, IL790th2026-10-15

Related records

DeviceEstablishmentPulse: Contract sterilizer 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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