FDA Registration
Active
🇨🇳 China
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
Reg #: 3004443928
·
FEI: 3004443928
·
Expires 2026
Products
7
Proprietary Names
36
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
- Registration Number
- 3004443928
- FEI Number
- 3004443928
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 SHENGHUI SOUTH ROAD, NANTOU TOWN, ZHONGSHAN CITY
- City
- GUANGDONG
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K052811
Owner / Operator
- Firm Name
- TAIWAN AN I CO.,LTD.
- Operator Number
- 9021165
- Address
- NO.1 BEEN TING BEEN-TSUOH, VILLAGE, SHI-KOOU SHIANG
- City
- CHIA-YI SHIANN
- State
- TW-NOTA
- Postal Code
- --
- Country
- TW
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2014-04-08 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2011-01-14 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2004-03-10 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2007-11-04 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2012-07-30 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2007-08-03 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2002-03-27 |
Proprietary Names
JOHN BUNN
Padded Splint
Disposable Splint
Waterproof Splint
Drive
Medline
Guardian
Ferno 444 Traction Splint
Ferno 443 Traction Splint
Airgo
Trust Worth
Hugo
Breezy
STRIVE stroller
INSIGNIA
AMG USA
Transport chair
TECH MED Services
Fusion
Sparky
EVEREST JENNINGS
drive TM
Feather
Gazelle
Titan
Ferno 65 Scoop
RHYTHM
Alevo
Knee Walker
Stella
Swivelmate
MECHANICAL(MULTIPLE BRANDS)
TECH MED
cup holder
cane holder
GF
Establishment Types
Manufacture Medical Device