FDA Registration
Active
🇨🇳 China
Fomed Industries Inc
Reg #: 9680887
·
FEI: 3008439903
·
Expires 2026
Products
19
Proprietary Names
21
Establishment Types
3
Classifications
19
Registration Details
- Registration Name
- Fomed Industries Inc
- Registration Number
- 9680887
- FEI Number
- 3008439903
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 20 Han Sha Road, Hou Hu District
- City
- Qian Jiang Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220512
Owner / Operator
- Firm Name
- Fomed Industries Inc.
- Operator Number
- 9010881
- Address
- 20 Han Sha Road, Hou Hu District
- City
- Qian Jiang
- State
- CN-NOTA
- Postal Code
- 433115
- Country
- CN
- Correspondent
- ALAIN - PAN
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- Hui Hong
- Address
- 800 E WISHKAH ST # 1021,ABERDEEN,WA,98520-2915, UNITED STATES
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2024-08-08 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2024-08-08 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2016-08-16 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2012-08-29 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2013-03-27 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2008-10-07 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-04-26 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2025-06-11 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2024-08-08 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2016-08-16 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2024-04-19 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2024-08-08 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2018-05-23 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-05-23 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2012-06-13 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2024-08-08 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-08-29 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2012-08-29 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2019-06-03 |
Proprietary Names
Air / Water Syringe Tips
Mixing Bowl
Tray,Impression,Preformed(Impression tray)
Cotton Tip Applicator, Micro Applicators
Face Mask
NON-STERILE GUAZE SPONGE, Non Woven Sponges, ABD Pads, Tracheotomy sponges, IV Drain sponges, Cotton filled sponges,
Cotton filled gauze pad
Surgical Face Mask
Dental Barrier and Sleeves
Bouffant caps
Unit, Operative Dental, Accessories (Barrier Film), Half Chair Sleeves, Headrest covers Sleeves, Tray Sleeves
Surgical Gown (S, M, L, XL, XXL, XXXL); Reinforced Surgical Gown (S, M, L, XL, XXL, XXXL)
Lab Coats, Lab Jackets, Protection gowns
U&U Sterilization Pouch And Roll
SMMS wrap,CSR wrap
Bandage, Elastic, Gauze packing, Triangular bandage
Bandage, Elastic
Shoe covers
absorbent medical fiber
Cotton roll
Gown
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device