FDA Registration
Active
🇨🇳 China
CHANGZHOU HOLYMED PRODUCTS CO., LTD
Reg #: 3006891803
·
FEI: 3006891803
·
Expires 2026
Products
16
Proprietary Names
25
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- CHANGZHOU HOLYMED PRODUCTS CO., LTD
- Registration Number
- 3006891803
- FEI Number
- 3006891803
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 525 CHANGWU ROAD SOUTH, WUJIN DISTRICT
- City
- CHANGZHOU Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210524
Owner / Operator
- Firm Name
- CHANGZHOU HOLYMED PRODUCTS CO., LTD
- Operator Number
- 10024103
- Address
- 525 CHANGWU ROAD SOUTH, WUJIN DISTRICT
- City
- CHANGZHOU
- State
- Jiangsu
- Postal Code
- 213167
- Country
- CN
- Correspondent
- XIAOMING WU
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2017-08-23 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2021-05-18 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-08-02 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-06-27 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2014-02-07 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-09 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2020-02-10 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2009-05-03 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2008-01-03 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2008-01-03 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2010-11-04 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2018-11-30 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2008-01-03 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2015-01-26 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2008-01-03 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2019-01-07 |
Proprietary Names
scurb suit
Surgical mask
Gauze / sponge
drape,surgical,gown surgical
ice bag
MASK, GAS, ANESTHETIC
shoe covers, boot covers, arm covers
Ortho Shorts
Coveralls
Stretcher Cover
Mastress sheet
Baby blanket
Infant shirt white
surgical gown
Isolation Mask
Stethoscope Cover
Lab Coats, Coveralls
Barrier Sleeve
Scurb Shirts/Pants
wrap,non-sterile
Patient cape
towel
protective clothing
Drape, surgical
nonwoven caps,bouffant caps, surgical caps
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility