FDA Registration
Active
🇨🇳 China
CHANGZHOU ELITE INTERNATIONAL CO.,LTD
Reg #: 3015698523
·
FEI: 3015698523
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- CHANGZHOU ELITE INTERNATIONAL CO.,LTD
- Registration Number
- 3015698523
- FEI Number
- 3015698523
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZOUQU TOWN ZHONGLOU DISTRICT
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- CHANGZHOU ELITE INTERNATIONAL CO.,LTD
- Operator Number
- 10060998
- Address
- ZOUQU TOWN ZHONGLOU DISTRICT
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213147
- Country
- CN
- Correspondent
- LILI JIANG
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 |
|---|---|---|---|---|---|
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2019-07-26 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2019-08-19 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2020-02-04 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2019-07-26 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-08-27 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2019-07-26 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2019-07-26 |
Proprietary Names
RECHARGEABLE TOOTHBRUSH & REPLACEMENT HEAD
Walker Glides
RAISED TOILET SEAT
UNDER PAD; CHAIR PAD; SHEET SET
WRIST BRACE
PILL ORGANIZER
CANE; QUAD CANE FEET
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device