FDA Registration
Active
🇨🇳 China
Device Name: Safety Needles
Reg #: 3012552122
·
FEI: 3012552122
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI MEKON MEDICAL DEVICES CO., LTD.
- Registration Number
- 3012552122
- FEI Number
- 3012552122
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 526, No. 697-3 Lingshi Road Shanghai China
- City
- shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212972
Owner / Operator
- Firm Name
- Shanghai Mekon Medical Devices Co., Ltd.
- Operator Number
- 10059181
- Address
- 526, No. 697-3 Lingshi Road Shanghai China
- City
- shanghai
- State
- CN-SH
- Postal Code
- 200072
- Country
- CN
- Correspondent
- Xuanjin Qu
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 |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-12-01 |
Proprietary Names
Device Name: Safety Needles
Establishment Types
Export Device to the United States But Perform No Other Operation on Device