Suzhou Prosteri Medical Technology Co., Ltd. (contract sterilizer, Suzhou Jiangsu, CN): 7 new FDA device listings, incl. device, neurovascular embolization
Suzhou Prosteri Medical Technology Co., Ltd. (Suzhou Jiangsu): 7 new FDA device listings, incl. device, neurovascular embolization. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 64 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: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x 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 | Suzhou Prosteri Medical Technology Co., Ltd. |
| Owner / operator | Suzhou ProSteri Medical Technology Co., Ltd. |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Suzhou Jiangsu, CN |
| New listings | 7 |
| Devices | Device, Neurovascular Embolization; Device, Vascular, For Promoting Embolization; Bronchoscope (Flexible Or Rigid); Catheters, Transluminal Coronary Angioplasty, Percutaneous; Ureteroscope And Accessories, Flexible/Rigid; Cystoscope And Accessories, Flexible/Rigid |
| Product codes | HCG, KRD, EOQ, LOX, FGB, FAJ |
| Device classes | Class II |
| Medical specialties | Neurology, Cardiovascular, Ear, Nose, Throat, Gastroenterology, Urology |
| Brand names | Numen Helia Coil Embolization System; NumenFR Detachment System; Broncho Videoscope System; Firefighter Pro PTCA Balloon Catheter; Single-use Flexible Ureteroscope SUV-5C-B; Urology Videoscope System |
| First new listing | 2026-06-08 |
| Latest new listing | 2026-09-02 |
| FDA registration number | 3017961114 |
| Registration expires | 2026-12-31 |
| amount percentile | 90th of 2,570 (median 1, 7.0x 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: 2026-09-02
- 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: Suzhou Prosteri Medical Technology Co., Ltd. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Suzhou Prosteri Medical Technology Co., Ltd.'s amount: 90th 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 Suzhou Prosteri Medical Technology Co., Ltd. in Suzhou Jiangsu?
Suzhou Prosteri Medical Technology Co., Ltd. (Suzhou Jiangsu, CN), a contract sterilizer, added 7 FDA device listings between 2026-06-08 and 2026-09-02.
How does Suzhou Prosteri Medical Technology Co., Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 64 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.
Suzhou Prosteri Medical Technology Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou Jiangsu, CN | 7 | 90th | 2026-09-02 |
| Isomedix Operations, Inc | Ontario, CA | 7 | 90th | 2026-10-15 |
| Isomedix Operations, Inc. | Libertyville, IL | 7 | 90th | 2026-10-15 |
| Isomedix Operations, Inc. | Temecula, CA | 7 | 90th | 2026-10-14 |
Related records
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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.