Gcmedica Enterprise Ltd. (Wuxi)
Wuxi Jiangsu, CN
GCMEDICA ENTERPRISE LTD. (WUXI) appears in FDA device records in Wuxi Jiangsu, CN. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Gcmedica Enterprise Ltd. (Wuxi) between 2019 and 2025. The busiest year on record is 2019, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2025 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007681502 | 3007681502 | GCMEDICA ENTERPRISE LTD. (WUXI) | Loujin Industrial Park,Shuofang, Wuxi Jiangsu 214143 CN | 2026 | and 16 more, listed in full below |
| 3018503755 | 3018503755 | GCMEDICA ENTERPRISE LTD.(WUXI) | 18 Xinjin road,Xinwu Industrial Zone,Wuxi,214000,China, WUXI Jiangsu 214000 CN | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- IKXAid, Transfer
- CAEAirway, Oropharyngeal, Anesthesiology
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- FNYBasin, Emesis
- KTCBath, Sitz, Nonpowered
- KDQBottle, Collection, Vacuum
- KBIBougie, Eustachian
- GECBrush, Scrub, Operating-Room
- KQMCamera, Surgical And Accessories
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- GBSCatheter, Ventricular, General & Plastic Surgery
- BSYCatheters, Suction, Tracheobronchial
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- KYWContainer, Liquid Medication, Graduated
- MMKContainer, Sharps
- HHKCurette, Suction, Endometrial (And Accessories)
- HCYCurette, Uterine
- KICCushion, Flotation
- FRZDevice, Patient Transfer, Powered
- NXBDispenser, Solid Medication
- GHYHematocrit, Tube, Rack, Sealer, Holder
- KZDInfusor, Pressure, For I.V. Bags
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- KDDKit, Surgical Instrument, Disposable
- FTALight, Surgical, Accessories
- BYGMask, Oxygen
- KGBMask, Oxygen, Non-Rebreathing
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- IQKOrthosis, Cervical
- IPYOrthosis, Lumbo-Sacral
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type
- LHISet, I.V. Fluid Transfer
- ILISling, Arm
- GAESnare, Surgical
- HIBSpeculum, Vaginal, Nonmetal
- ILHSplint, Hand, And Components
- BSRStylet, Tracheal Tube
- IOYSupport, Arm
- KCPSyringe, Ent
- KYZSyringe, Irrigating (Non Dental)
- LJHSystem, Irrigation, Urological
- EYHTable, Cysto, Non-Electrical
- INPTips And Pads, Cane, Crutch And Walker
- BYZTrap, Sterile Specimen
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- GAZTubing, Noninvasive
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
- FNPUrinal
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain