Sterigenics Shanghai ETO Ltd. (contract sterilizer, Shanghai, CN): 4 new FDA device listings, incl. gown, surgical
Sterigenics Shanghai ETO Ltd. (Shanghai): 4 new FDA device listings, incl. gown, surgical. Its amount of 4 is above the median of 1 (83rd percentile). Dated 174 days ago, it serves as a historical benchmark. Score 70/100. 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: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x 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.
| Field | Value |
|---|---|
| Establishment | Sterigenics Shanghai ETO Ltd. |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Shanghai, CN |
| New listings | 4 |
| Devices | Gown, Surgical; Needle, Hypodermic, Single Lumen; Syringe, Piston; Syringe, Antistick |
| Product codes | FYA, FMI, FMF, MEG |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, General Hospital |
| Brand names | Cardinal luer lock syringe with safety needle |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-05-14 |
| FDA registration number | 3007007790 |
| Registration expires | 2026-12-31 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
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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: 2026-05-14
- 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: Sterigenics Shanghai ETO Ltd. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Sterigenics Shanghai ETO Ltd.'s amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Sterigenics Shanghai ETO Ltd. in Shanghai?
Sterigenics Shanghai ETO Ltd. (Shanghai, CN), a contract sterilizer, added 4 FDA device listings between 2026-05-12 and 2026-05-14.
How does Sterigenics Shanghai ETO Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 174 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Sterigenics Shanghai ETO Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai, CN | 4 | 83rd | 2026-05-14 |
| Isomedix Operations Inc. | Chester, NY | 3 | 77th | 2026-09-28 |
| Isomedix Operations, Inc | Ontario, CA | 7 | 90th | 2026-10-15 |
| Isomedix Operations, Inc. | Libertyville, IL | 7 | 90th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: Foreign establishment
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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.