Data / Medical devices / China / Qingdao London Durex Co., Ltd.
Qingdao London Durex Co., Ltd.: FDA-registered device maker in Qingdao Shandong, China, 2 510(k) clearances
Qingdao London Durex Co., Ltd. is registered with the FDA (registration 3008559248) in Qingdao Shandong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 7, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008559248
- Address
- No. 1-13 Shangma Part Aodong Road, Chengyang, Qingdao Shandong, China, 266114
- Owner or operator
- Reckitt Benckiser LLC (9004884)
- Roles
- Manufacturer
- First device listed
- March 24, 2023
- Registered through
- 2026
- Brand names listed
- Durex Adventure Pack, Durex Air Close Fit, Durex Air Regular Fit, Durex Extra Sensitive Close, Durex Extra Sensitive Regular, Durex Extra Sensitive Smooth, Durex Extra Sensitive Thin, Durex Pleasure Pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | 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 |
|---|---|---|---|---|---|---|
| November 7, 2022 | K220489 | Durex Patronus CloseFit, Durex Patronus Regular | HIS | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| October 12, 2022 | K222068 | Durex Penck III Regular | HIS | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
Compare with other makers
Updated November 7, 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.