FDA Registration
Active
🇨🇳 China
ARROW MEDSOURCE GROUP LIMITED
Reg #: 3016685880
·
FEI: 3016685880
·
Expires 2026
Products
17
Proprietary Names
10
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- ARROW MEDSOURCE GROUP LIMITED
- Registration Number
- 3016685880
- FEI Number
- 3016685880
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FLAT 10, 3/F WAH YIU INDUS, 30-32 AU PUI WAN STREET SHA, TIN, NT
- City
- Hongkong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K123787
Owner / Operator
- Firm Name
- Arrow Medsource Group Limited
- Operator Number
- 10064458
- Address
- FLAT 10, 3/F WAH YIU INDUS , 30-32 AU PUI WAN STREET SHA TIN, NT
- City
- Hongkong
- State
- CN-NOTA
- Postal Code
- None
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-04-03 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-04-17 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-07-27 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-01 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2021-05-18 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-05-18 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2020-04-17 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-04-17 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-25 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2024-02-26 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2024-02-27 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-02-23 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2021-02-23 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-02-23 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-17 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-20 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-02-27 |
Proprietary Names
Bouffant Cap
Ophthalmic Eye Shield
Isolation Gown, Chemo Gown; Coverall with tape; Coverall w/o tape; Disposable Coverall; Disposable Isolation Gown
Polymer Patient Examination Glove
Disposable Shoe Covers
Gown Examination
Tubing, Noninvasive
AMG
General Face Mask
Catheter And Tip, Suction
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)