Gcmedica Enterprise Ltd.(Wuxi)
Manufacturer and brand owner in Wuxi, Jiangsu, China. 55 device types, 22 products catalogued, 2 clearances.
Gcmedica Enterprise Ltd.(Wuxi) is a contract manufacturer holding a current FDA establishment registration. The registration covers Urinal, Sling, Arm and 53 other device types. 22 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
55device types registered with the FDA
22products catalogued under its own name
2510(k) clearances
Registration
| Registered name | GCMEDICA ENTERPRISE LTD.(WUXI) |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018503755 |
| FEI number | 3018503755 |
| DUNS | 560122957 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 无锡市九龙医疗器械有限公司 |
|---|---|
| Unified social credit code | 913202147424843314 |
| Source | NMPA UDI database |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | 18 Xinjin road,Xinwu Industrial Zone,Wuxi,214000,China |
| Postal code | 214000 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Rigid Uterine Aspiration Curette | HHK | 18 |
| Closed Suction Catheter | BSY | 8 |
| Flexible Uterine Aspiration Curette | HHK | 5 |
| Natus | CAT | 4 |
| Gcmedica | LHI | 4 |
| Disposable Urinary Leg Bag | FAQ | 3 |
| Arm Sling | ILI | 2 |
| Knee Brace | ITQ | 2 |
| Thoracic catheter | GBS | 2 |
| Orthopedic Suction Set | JOL | 2 |
| Back Brace | IPY | 1 |
| Orthopaedic Suction Set | JOL | 1 |
| Thumb Support | ILH | 1 |
| Elbow Support | IOY | 1 |
| Compression Gloves | ILH | 1 |
| Disposable Urinary Drainage Bag | KNX | 1 |
| Dynarex Corporation | GCX | 1 |
| Cervical Collar | IQK | 1 |
| Ankle Support | ITW | 1 |
| Shoulder Brace | IOY | 1 |
| Wrist Support | ILH | 1 |
| De Soutter Medical | BYY | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251882 | 2025-10-16 | HHK | Traditional | This company |
| K182819 | 2019-12-02 | LHI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 500 |
| Factory area | 67200 |
| Main products | respiratory supplies, anesthesia equipment, enteral nutrition devices, laparoscopic instruments, urology supplies |
| Certifications | ISO13485, CE, FDA, TUV Rheinland, UKCA |
| Export markets | 80+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.