Data / Medical devices / United Kingdom / Daye (anne's Day Ltd)
Daye (anne's Day Ltd): FDA-registered device maker in London London, City of, United Kingdom, 1 510(k) clearance
Daye (anne's Day Ltd) is registered with the FDA (registration 3036679730) in London London, City of, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036679730
- Address
- 4th Floor 22 Southwark Bridge Road, London London, City of, United Kingdom, SE1 9HF
- Owner or operator
- Daye (Anne's Day Ltd) (10088636)
- Roles
- Specification developer
- First device listed
- September 11, 2023
- Registered through
- 2026
- Brand names listed
- Daye Hemp Pads, Daye Organic Tampons, Daye Vaginal Tampon Swab, Daye at-Home Microbiome Screening, Daye at-Home Vaginal Microbiome Screen, Vaginal Microbiome Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Specification developer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 18, 2023 | K223883 | Daye Tampon | HEB | Substantially Equivalent | Annes Daye, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 17, 2025 | 97718 | Class II | Ongoing | 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009 | Product lacks 510(k) clearance. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Pad, Menstrual, Unscented
- All makers of Tampon, Menstrual, Unscented
Updated October 28, 2025. 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.