FDA Registration
Active
🇺🇸 United States
HAOLANG MEDICAL USA CORPORATION
Reg #: 3016727301
·
FEI: 3016727301
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- HAOLANG MEDICAL USA CORPORATION
- Registration Number
- 3016727301
- FEI Number
- 3016727301
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8623 NE 26th Pl
- City
- Clyde Hill
- State
- WA
- ZIP
- 98004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120548
Owner / Operator
- Firm Name
- Haolang Medical USA Corporation
- Operator Number
- 10065877
- Address
- 1100 Bellevue Way NE 8A-533
- City
- Bellevue
- State
- WA
- Postal Code
- 98004
- Country
- US
- Correspondent
- Lisa Xu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2020-04-02 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-04-02 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2025-05-19 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2020-04-02 |
| Catheter, Umbilical Artery | FOS | Class 2 | General Hospital | No | 2021-05-19 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-07-30 |
Proprietary Names
NEEDLE-LESS VALVE
NEXUS MIDLINE CATHETER
Hemodialysis Catheter
ORION II CT CVC
Peripheral Inserted Central Catheter
Umbilical Vessels Catheter
Arterial Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility