Coloplast (China) Ltd.
Registered establishment in Zhuhai, Guangdong, China. 5 device types.
Coloplast (China) Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Collector, Ostomy, Catheter, Straight and 3 other device types. Its earliest product listing with the FDA dates from 1995.
Registration
| Registered name | COLOPLAST (CHINA) LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005945907 |
| FEI number | 3005945907 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 康乐保（中国）有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | No. 202, Bao Cheng Road |
| Postal code | 519030 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | Conveen Active, Conveen Contour, Conveen Standard, Coloplast Urostomy night bag, Conveen Urine Bag Hanger, Conveen Leg Bag Strap and 1 more | 2004 | 47 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Conveen Contour, Conveen Security+ | 1995 | 52 |
| Catheter, Straight | Class 2 | Self-Cath Plus, Self-Cath | 2023 | 21 |
| Collector, Ostomy | Class 1 | Assura Urostomy bag, SenSura Mio Convex High Output ostomy bag, SenSura Mio Original, Sensura Mio Flex, Brava Paste, SenSura Mio Baby ostomy baseplate and 53 more | 2005 | 18 |
| Device, Incontinence, Urosheath Type, Non-Sterile | Class 1 | Freedom, Penilex, Conveen Optima, Self-Cath Extension Tube, Conveen Security + | 2007 | 13 |
Clearances
No clearance names Coloplast (China) Ltd. as applicant. One is held by another company 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 |
|---|---|---|---|---|
| K221401 | 2022-12-02 | EZD | Traditional | Coloplast |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Employees | 800 |
| Factory area | 100,000 square meters |
| Main products | Ostomy care products, Urology products, Continence care, Wound and skin care |
| Export markets | Global |
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.