Data / Medical devices / China / Fujian Time And Tianhe Industrial Co., Ltd
Fujian Time And Tianhe Industrial Co., Ltd: FDA-registered device maker in Nanan Fujian, China, 1 510(k) clearance
Fujian Time And Tianhe Industrial Co., Ltd is registered with the FDA (registration 3008381943) in Nanan Fujian, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008381943
- Address
- Honggongshan Development Zone Honglai Town, Nanan Fujian, China, 362331
- Owner or operator
- FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD (10032327)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- May 3, 2010
- Registered through
- 2026
- Brand names listed
- Adult Diaper, Adult Pant, Diaper, Face Mask, JFH00896 Just for Her® Menstrual Pads Maxi Pads with Wings, Overnight, JFH00897 Just for Her® Menstrual Pads Maxi Pads with Wings, Long super, JFH00898 Just for Her®Menstrual Pads Maxi Pads with Wings, Regular, Maternity Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Maternity Kit | PVT | 1 | Contract manufacturer, Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 30, 2022 | K222046 | Unscented Menstrual Tampon | HEB | Substantially Equivalent | Suzhou Borage Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Menstrual, Unscented
- All makers of Respirator, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Fiber, Medical, Absorbent
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Maternity Kit
Updated September 30, 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.