FDA Registration
Active
🇨🇳 China
SHANDONG CAREMED MEDICAL PRODUCTS CO.,LTD.
Reg #: 3012461127
·
FEI: 3012461127
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
2
Classifications
6
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Registration Details
- Registration Name
- SHANDONG CAREMED MEDICAL PRODUCTS CO.,LTD.
- Registration Number
- 3012461127
- FEI Number
- 3012461127
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- YanTai Industrial Park, Ding Tao Country, East of Zhanqian Road
- City
- Heze Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K132553
Owner / Operator
- Firm Name
- Shandong Caremed Medical Products Co.,Ltd.
- Operator Number
- 10050312
- Address
- YanTai Industrial Park, Ding Tao Country, East of Zhanqian Road
- City
- Heze
- State
- Shandong
- Postal Code
- 274100
- Country
- CN
- Correspondent
- Haibo Li
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 |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-11-02 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2017-05-17 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2017-06-29 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2017-02-15 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-02-23 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2017-04-06 |
Proprietary Names
Syringe, piston
Needle, hypodermic, single lumen
NEEDLE, DENTAL
Insulin Syringe, piston
Set, administration, intravascular
Syringe, irrigating (dental)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device