Boen Healthcare Co., Ltd. (specification developer, Suzhou Jiangsu, CN): 125 new FDA device listings, incl. apparatus, suction, operating-room, wall vacuum powered
Boen Healthcare Co., Ltd. (Suzhou Jiangsu): 125 new FDA device listings, incl. apparatus, suction, operating-room, wall vacuum powered. Its amount of 125 is top-decile (99th percentile of 2,570 records). Dated 64 days ago, it serves as a historical benchmark. Score 75/100. 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: 125 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 125.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Boen Healthcare Co., Ltd. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Suzhou Jiangsu, CN |
| New listings | 125 |
| Devices | Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Cup, Prophylaxis; Connector, Airway (Extension); Silicone Hydrogel For Scar Management; Device, Incontinence, Urosheath Type, Non-Sterile; Clinical Electronic Thermometer; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Drape, Adhesive, Aerosol; Accessories, Retractor, Dental; Brush, Cleaning, Tracheal Tube |
| Product codes | GCX, EHK, BZA, PFP, NNX, SDV, LXG, KGT, EIF, EPE, FOG, ISD, LWH, FQL, GDJ |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Dental, Anesthesiology, General, Plastic Surgery, Gastroenterology, Urology, Clinical Chemistry, Physical Medicine, Pathology, Orthopedic, Ear, Nose, Throat, Obstetrics/Gynecology, Cardiovascular, Hematology, Microbiology |
| Brand names | Fluid Fighter Suction Mat; Suction Mat; Suction Ring; Suction Ring With Tubing; Apparatus Suction; Suction Catheter; Karl Hammacher GmbH; Choking Rescue Device; Prophylaxis Cup; Prophy Cup; Airway Adapter; Scar Gel; Silicone Scar Dressing; Scar Gel Sheet; Device, Incontinence, Urosheath Type, Non-Sterile |
| First new listing | 2026-05-06 |
| Latest new listing | 2026-09-01 |
| FDA registration number | 3045058049 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 125.0x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-01
- 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: Boen Healthcare Co., Ltd. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Boen Healthcare Co., Ltd.'s amount: 99th 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)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Boen Healthcare Co., Ltd. in Suzhou Jiangsu?
Boen Healthcare Co., Ltd. (Suzhou Jiangsu, CN), a specification developer (outsources manufacturing), added 125 FDA device listings between 2026-05-06 and 2026-09-01.
How does Boen Healthcare Co., Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 125 is 125.0x 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 75/100 puts it among the stronger signals in this feed.
Boen Healthcare Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, CN | 125 | 99th | 2026-09-01 |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL | 144 | 99th | 2026-10-08 |
| Arthrex, Inc. | Naples, FL | 12 | 95th | 2026-09-27 |
| Boston Scientific Corporation | Marlborough, MA | 9 | 92nd | 2026-10-16 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) 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.