Data / Medical devices / Singapore / Hytto Pte. Ltd.
Hytto Pte. Ltd.: FDA-registered device maker in Singapore Central Singapore, Singapore, 1 510(k) clearance
Hytto Pte. Ltd. is registered with the FDA (registration 3029906446) in Singapore Central Singapore, Singapore. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029906446
- Address
- 152 Beach Road, #11-05 Gateway East, Singapore Central Singapore, Singapore, 189721
- Owner or operator
- HYTTO PTE. LTD. (10088903)
- Roles
- Exporter to the US
- First device listed
- October 19, 2023
- Registered through
- 2026
- Brand names listed
- Diamo, LOVENSE Personal Lubricant Jelly
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, External Penile Rigidity | LKY | 2 | Exporter to the US | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 18, 2021 | K202667 | Personal Lubricant Jelly | NUC | Substantially Equivalent | Nantong Health & Beyond Hygienic Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2021. 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.