Data / Medical devices / Taiwan / Innovemed Bio-Tech Co., Ltd.
Innovemed Bio-Tech Co., Ltd.: FDA-registered device maker in New Taipei, Taiwan, 2 510(k) clearances
Innovemed Bio-Tech Co., Ltd. is registered with the FDA (registration 3029905133) in New Taipei, Taiwan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 11, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029905133
- Address
- 4F., No. 139, Fuhe Rd., Yonghe Dist., New Taipei, Taiwan, 234
- Owner or operator
- InnoveMed Bio-tech Co., Ltd. (10088871)
- Roles
- Manufacturer
- First device listed
- October 17, 2023
- Registered through
- 2026
- Brand names listed
- Play and Joy AIR Silicone Lubricant, model AA-050013, Play and Joy AIR Silicone Lubricant, model AA-100006, Play and Joy ARTMIS Exosome Herbal Orgasm Drop, model AA-035003, Play and Joy ARTMIS Exosome Herbal Orgasm Drop, model AA-035004, Play and Joy InvisiLube Lubricant Capsule, model AA-010005, Play and Joy InvisiLube Lubricant Capsule, model AA-010006, Play and Joy InvisiLube Lubricant Capsule, model PJ-CP101-10-EU, Play and Joy InvisiLube Lubricant Capsule, model PJ-CP102-10-EU and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 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 |
|---|---|---|---|---|---|---|
| July 11, 2023 | K221137 | Play and Joy Water-Based Lubricant | NUC | Substantially Equivalent | Innovemed Bio-Tech Co., Ltd. | accessdata.fda.gov |
| July 10, 2023 | K220646 | Play&Joy InvisiLube Lubricant Capsule | NUC | Substantially Equivalent | Innovemed Bio-Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 11, 2023. 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.