FDA Registration
Active
🇨🇳 China
Crown Name Disposable Hygiene Products Fty. Ltd.
Reg #: 3010155681
·
FEI: 3010155681
·
Expires 2026
Products
11
Proprietary Names
1
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- Crown Name Disposable Hygiene Products Fty. Ltd.
- Registration Number
- 3010155681
- FEI Number
- 3010155681
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.508 Qi'an Avenue, Zhucheng Street,, Xinzhou District
- City
- Wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203534
Owner / Operator
- Firm Name
- Crown Name Disposable Hygiene Products Fty. Ltd.
- Operator Number
- 10042236
- Address
- 19F, Block B, Tinyuet Bund Finance Centre, No.8 Sanyang Road,
- City
- Wuhan
- State
- Hubei
- Postal Code
- 431400
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2012-11-02 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2016-07-08 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2016-07-08 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2016-07-08 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2017-01-13 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2014-08-20 |
| 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 | 2020-04-28 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2016-07-08 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-08-09 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-11-19 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2022-06-01 |
Proprietary Names
Disposable Surgical Isolation Gown
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device