FDA Registration
Active
🇨🇳 China
Non-breathing Oxygen 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 |
|---|---|---|---|---|---|
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2020-02-27 |
Proprietary Names
Non-breathing Oxygen Mask
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device