Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 14 device types, 3 products catalogued.
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Stapler, Skin, Endoscopic Bite Block and 12 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | CHANGZHOU INTL. TRADE & ENTERPRISES COOPERATIVE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010612620 |
| FEI number | 3010612620 |
| DUNS | 545070385 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.20 Floor, Huajing Building, No.1 Hejing Garden, Zhonglou District |
| Postal code | 213000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Cleaning Brushes for Endoscope | 2022 | 43 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | Class 1 | Air/Water Channel Cleaning Adapter, Suction Cleaning Adapter | 2022 | 6 |
| Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | Class 2 | Dilators | 2022 | 3 |
| Endoscope Channel Accessory | Class 2 | Disposable Endoscope Valves System | 2022 | 21 |
| Endoscopic Bite Block | Class 1 | Disposable Bite Blocks | 2022 | 44 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Disposable Grasping Forceps | 2022 | 21 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Non-vascular Guidewires | 2022 | 21 |
| Endoscopic Irrigation/Suction System | Class 2 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | 2022 | 10 |
| Forceps, Biopsy, Non-Electric | Class 1 | Disposable Biopsy Forceps, Disposable Rotatable Biopsy Forceps | 2022 | 44 |
| Instrument, Surgical, Disposable | Class 1 | Skin Staple Removers | 2022 | 45 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Class 2 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | 2022 | 5 |
| Laparoscope, General & Plastic Surgery | Class 2 | Disposable Specimen Retrieval Bag | 2020 | 46 |
| Stapler, Skin | Class 1 | Sterile disposable skin stapler | 2022 | 22 |
| Trap, Sterile Specimen | Class 2 | Polyp Traps | 2022 | 19 |
Own-Brand Listings
Clearances
No clearance names Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232244 | 2023-11-29 | ODC | Traditional | Changzhou Endoclean Medical Device Co., Ltd. |
| K221310 | 2022-10-07 | OCX | Traditional | Changzhou Endoclean Medical Device Co., Ltd. |
| K221331 | 2022-09-08 | ODC | Traditional | Changzhou Endoclean Medical Device Co., Ltd. |
| K200053 | 2020-04-21 | GCJ | Traditional | Dannik |
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.