Data / Medical devices / China / Gcmedica Enterprise Ltd.(wuxi)
Gcmedica Enterprise Ltd.(wuxi): FDA-registered device maker in WUXI Jiangsu, China, 2 510(k) clearances
Gcmedica Enterprise Ltd.(wuxi) is registered with the FDA (registration 3018503755) in WUXI Jiangsu, China. It lists 50 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3018503755
- Address
- 18 Xinjin road,Xinwu Industrial Zone,Wuxi,214000,China, WUXI Jiangsu, China, 214000
- Owner or operator
- GCMEDICA ENTERPRISE LTD.(WUXI) (10080904)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 4, 2021
- Registered through
- 2027
- Brand names listed
- Aspiration Tubing Set, Bulb Irrigation Syringe, Mucosal Atomization Device, Orthopedic Super Sucker Set, Sharp Container, Suction Connecting Tubes, Suture Retriever, Vein Cannual and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Contract manufacturer | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Applicator, Vaginal | HGD | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bath, Sitz, Nonpowered | KTC | 1 | Contract manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Ventricular, General & Plastic Surgery | GBS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Contract manufacturer | accessdata.fda.gov |
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Patient Transfer, Powered | FRZ | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Contract manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Snare, Surgical | GAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Table, Cysto, Non-Electrical | EYH | 1 | Manufacturer | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Contract manufacturer | accessdata.fda.gov |
| Trap, Sterile Specimen | BYZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Contract manufacturer | accessdata.fda.gov |
| Urinal | FNP | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| October 16, 2025 | K251882 | Uterine Aspiration Set | HHK | Substantially Equivalent | Gcmedica Enterprise Ltd.(Wuxi) | accessdata.fda.gov |
| December 2, 2019 | K182819 | Decanting Device | LHI | Substantially Equivalent | Gcmedica Enterprise Ltd.(Wuxi) | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Oxygen
- All makers of Tubing, Noninvasive
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Curette, Suction, Endometrial (And Accessories)
Updated October 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.