FDA Registration
Active
🇨🇳 China
Berpu Medical Technology Co., Ltd.
Reg #: 3004496829
·
FEI: 3004496829
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Berpu Medical Technology Co., Ltd.
- Registration Number
- 3004496829
- FEI Number
- 3004496829
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.14 Xingji Road, Yongxing Street, Longwan District
- City
- WENZHOU Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K162180
Owner / Operator
- Firm Name
- Berpu Medical Technology Co., Ltd.
- Operator Number
- 9061974
- Address
- No. 14 Xingji Road, Yongxing Street, Longwan Distric
- City
- Wenzhou
- State
- Zhejiang
- Postal Code
- 325000
- Country
- CN
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2026-02-04 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-03-06 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2022-07-12 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2015-01-28 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2020-09-10 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2018-02-04 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2018-09-04 |
Proprietary Names
cobas sense venous pipettes
Syringe, piston
CONTAINER, SPECIMEN, STERILE
ONE-CARE pen needle
Sterile Dental Needles for Single Use
Sterile Irrigation Needle for Single Use
Blunt Fill Needle
Insulin pen needle
Needle, hypodermic, single lumen
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)