Data / Medical devices / China / Coloplast (china) Ltd.
Coloplast (china) Ltd.: FDA-registered device maker in ZHUHAI Guangdong, China, 1 510(k) clearance
Coloplast (china) Ltd. is registered with the FDA (registration 3005945907) in ZHUHAI Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 2, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005945907
- Address
- No. 202, Bao Cheng Road ZHUHAI FREE TRADE ZONE, ZHUHAI Guangdong, China, 519030
- Owner or operator
- Coloplast Corp. (8010144)
- Roles
- Manufacturer
- First device listed
- November 2, 1995
- Registered through
- 2027
- Brand names listed
- Assura 1pc Kit, Assura CV Kit, Assura Kit, Assura Night bag, Assura Ostomy Pouch, Assura Urostomy Pouch, Assura Urostomy bag, Brava Belt for SenSura Mio and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Manufacturer | accessdata.fda.gov |
| Collector, Ostomy | EXB | 1 | Manufacturer | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 2, 2022 | K221401 | Self-Cath and Self-Cath Plus | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
Compare with other makers
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Device, Incontinence, Urosheath Type, Non-Sterile
- All makers of Collector, Ostomy
- All makers of Catheter, Straight
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
Updated December 2, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.