Fujian Time AND Tianhe Industrial Co., Ltd.
Registered establishment in Nanan, Fujian, China. 9 device types.
Fujian Time AND Tianhe Industrial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Maternity Kit, Respirator, Surgical and 7 other device types. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008381943 |
| FEI number | 3008381943 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Nanan |
|---|---|
| Province | Fujian |
| Address | HONGGONGSHAN DEVELOPMENT ZONE |
| Postal code | 362331 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Mask | 2020 | 439 |
| Cover, Mattress (Medical Purposes) | Class 1 | Nursing Pad/Under Pad | 2024 | 89 |
| Fiber, Medical, Absorbent | Class 1 | Adult Pant, Adult Diaper | 2024 | 172 |
| Garment, Protective, For Incontinence | Class 1 | Diaper | 2016 | 181 |
| Maternity Kit | Class 1 | Maternity Kit, Tampon, Maxi Pad Super w/wings, Ultra-Thin Pad w/wings, Feminine Hygiene Wipe | 2024 | 2 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | Class 1 | Sanitary Napkin | 2010 | 29 |
| Pad, Menstrual, Unscented | Class 1 | JFH00898 Just for Her®Menstrual Pads Maxi Pads with Wings, Regular, JFH00897 Just for Her® Menstrual Pads Maxi Pads with Wings, Long super, Panty Liner, JFH00896 Just for Her® Menstrual Pads Maxi Pads with Wings, Overnight | 2010 | 132 |
| Respirator, Surgical | Class 2 | Respirator KN90,KN95,KN100 | 2020 | 118 |
| Tampon, Menstrual, Unscented | Class 2 | Tampons | 2024 | 10 |
Clearances
No clearance names Fujian Time AND Tianhe Industrial Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222046 | 2022-09-30 | HEB | Traditional | Suzhou Borage Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1997 |
|---|---|
| Factory area | 100000 sq m |
| Main products | Baby diapers, Sanitary napkins, Adult diapers, Nursing pads, Baby wipes |
| Certifications | ISO9001, ISO13485, FDA, SGS HALAL, FSC, OEKO TEX 2005 |
| Export markets | 89+ overseas distributors |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| AAB (China) Co., Ltd. | 9 |
| Nan’an Hengyuan Hygiene Products Co., Ltd. | 9 |
| Fujian Quanzhoucity Aile Hygiene Products Co., Ltd. | 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.