# Boen Healthcare Co., Ltd. (specification developer, Suzhou Jiangsu, CN): 125 new FDA device listings, incl. apparatus, suction, operating-room, wall vacuum powered

**Score:** 75/100

| 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 |

## Why this 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.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
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.