K-MED Co., Ltd.
Registered establishment in Yangzhou, Jiangsu, China. 20 device types, 4 clearances.
K-MED Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Bedpan, Enema Kit and 18 other device types. Its earliest product listing with the FDA dates from 2021.
20device types registered with the FDA
4510(k) clearances
Registration
| Registered name | K-MED CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014615175 |
| FEI number | 3014615175 |
| Establishment type | Manufacturer |
Location
| City | Yangzhou |
|---|---|
| Province | Jiangsu |
| Address | F5, No 18 West Wenchang Road |
| Postal code | 225009 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Fecal Collection Bag; Collection Bag | 2024 | 193 |
| Appliance, Colostomy, Disposable | Class 1 | Appliance, colostomy, disposable | 2022 | 8 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | BAG, Urine Collection, LEG, FOR External USE, NON-Sterile | 2022 | 47 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | BAG, Urine Collection, LEG, FOR External USE, Sterile | 2021 | 52 |
| Bandage, Cast | Class 1 | Bandage, Cast | 2023 | 81 |
| Bandage, Elastic | Class 1 | Bandage, Elastic | 2023 | 280 |
| Basin, Emesis | Class 1 | Basin, Emesis | 2022 | 65 |
| Bedpan | Class 1 | Bedpan | 2022 | 34 |
| Bottle, Collection, Vacuum | Class 2 | Suction Liner | 2024 | 88 |
| Cannula, Injection | Class 1 | Cannula, Injection | 2021 | 12 |
| Cannula, Nasal, Oxygen | Class 1 | Cannula, Nasal, Oxygen | 2021 | 97 |
| Collector, Urine, Powered, Non Indwelling Catheter | Class 1 | Collector, urine, powered, non indwelling catheter | 2022 | 13 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | Class 1 | Container, Specimen, Urine, Drugs OF Abuse, Over THE Counter | 2022 | 6 |
| Enema Kit | Class 1 | Enema kit | 2021 | 24 |
| Forceps, Dressing, Dental | Class 1 | Forceps, Dressing, Dental | 2023 | 22 |
| Holder, Ureteral Catheter | Class 1 | Medical Tube Holder | 2024 | 29 |
| Mask, Oxygen | Class 1 | Mask, Oxygen | 2021 | 126 |
| Pouch, Colostomy | Class 1 | Pouch, colostomy | 2022 | 25 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | Class 1 | System, Urine Drainage, Closed, FOR NON-Indwelling Catheter, NON-Sterile | 2022 | 13 |
| Tape And Bandage, Adhesive | Class 1 | Adhensive tape and bandage, Medical tapes | 2023 | 353 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K832566 | 1983-11-28 | FFK | Traditional | This company |
| K812025 | 1981-08-31 | Traditional | This company | |
| K812026 | 1981-08-31 | Traditional | This company | |
| K810641 | 1981-05-13 | BWF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 3000 ㎡ |
|---|---|
| Main products | Urine drainage bags, Wound dressing, Oxygen masks, Medical catheters, Feeding tubes |
| Certifications | CE, EU MDR, ISO 13485 |
| Export markets | 50+ countries including South America, Europe, Asia, Middle East, North America |
| 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.
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