FDA Registration
Active
🇨🇳 China
JIAXING XINYI MEDICAL INSTRUMENT CO., LTD.
Reg #: 3011669224
·
FEI: 3011669224
·
Expires 2026
Products
12
Proprietary Names
21
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- JIAXING XINYI MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3011669224
- FEI Number
- 3011669224
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.15,Jinyi Road,(1)and No.100 Zhijiang Road,, (2) Economic Development Zone Jiashan City Zhejiang, CHINA
- City
- Jiashan City Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K990463
Owner / Operator
- Firm Name
- Jiaxing Xinyi Medical Instrument Co., Ltd.
- Operator Number
- 10049114
- Address
- No.15,Jinyi Road,(1)and No.100 Zhijiang Road,, (2) Economic Development Zone Jiashan City Zhejiang, CHINA
- City
- Jiashan City
- State
- Zhejiang
- Postal Code
- 314100
- Country
- CN
- Correspondent
- Charles Shen
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln. ,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2015-04-15 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2015-04-15 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-25 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-25 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2018-01-18 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2015-04-15 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2015-04-15 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2015-04-15 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-03-29 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-29 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2015-04-15 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2016-05-10 |
Proprietary Names
manual bed
steel rollator
aluminum rollator
steel walker with castors
aluminum walker with castors
disposable face mask
Wheelchair
polio auxiliary cane
underarm crutch
single hand cane
tips and pads
cane
crutch and walker
aluminum shower chair with backrest
aluminum commode
steel commode with castors
round shower chair
Protective clothing
Isolation Gown
overbed table
Crutch
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device