FDA Registration
Active
🇨🇳 China
FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD
Reg #: 3008381943
·
FEI: 3008381943
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
4
Classifications
9
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Registration Details
- Registration Name
- FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD
- Registration Number
- 3008381943
- FEI Number
- 3008381943
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HONGGONGSHAN DEVELOPMENT ZONE, HONGLAI TOWN
- City
- Nanan Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222046
Owner / Operator
- Firm Name
- FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD
- Operator Number
- 10032327
- Address
- HONGGONGSHAN DEVELOPMENT ZONE, HONGLAI TOWN
- City
- NANAN CITY
- State
- Fujian
- Postal Code
- 362331
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charlie Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-11 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2024-11-05 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2016-12-23 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | Class 1 | Obstetrics/Gynecology | No | 2010-05-03 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-05-12 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2010-05-03 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2024-12-10 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2024-11-05 |
| Maternity Kit | PVT | Class 1 | Obstetrics/Gynecology | No | 2024-12-27 |
Proprietary Names
Face Mask
Nursing Pad/Under Pad
Diaper
Sanitary Napkin
Respirator KN90,KN95,KN100
JFH00896 Just for Her® Menstrual Pads Maxi Pads with Wings, Overnight
JFH00897 Just for Her® Menstrual Pads Maxi Pads with Wings, Long super
Panty Liner
JFH00898 Just for Her®Menstrual Pads Maxi Pads with Wings, Regular
Tampons
Adult Pant
Adult Diaper
Maternity Kit
Tampon, Maxi Pad Super w/wings, Ultra-Thin Pad w/wings, Feminine Hygiene Wipe
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device