FDA Registration
Active
🇨🇳 China
Disposable Face Mask
Reg #: 3013909820
·
FEI: 3013909820
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- NINGBO LUKE MEDICAL DEVICES CO., LTD.
- Registration Number
- 3013909820
- FEI Number
- 3013909820
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gujiayan, Yangming Road, 315400 Yuyao City, Zhejiang Province, China
- City
- Yuyao Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Ningbo Luke Medical Devices Co., Ltd.
- Operator Number
- 10056138
- Address
- Gujiayan, Yangming Road, 315400 Yuyao City, Zhejiang Province, China
- City
- Yuyao
- State
- Zhejiang
- Postal Code
- 315400
- Country
- CN
- Correspondent
- Yehua Zhang
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 |
|---|---|---|---|---|---|
| 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 | 2020-03-28 |
Proprietary Names
Disposable Face Mask
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)