FDA Registration
Active
🇨🇳 China
SHANGHAI HUAYUE PACKAGING PRODUCTS CO., LTD.
Reg #: 3004496839
·
FEI: 3004496839
·
Expires 2026
Products
18
Proprietary Names
22
Establishment Types
3
Classifications
18
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Registration Details
- Registration Name
- SHANGHAI HUAYUE PACKAGING PRODUCTS CO., LTD.
- Registration Number
- 3004496839
- FEI Number
- 3004496839
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.228, ZHAIXING RD., ZHELIN TOWN
- City
- FENGXIAN DISTRICT, SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K014239
Owner / Operator
- Firm Name
- SHANGHAI HUAYUE PACKAGING PRODUCTS CO., LTD.
- Operator Number
- 9061967
- Address
- NO.228, ZHAIXING RD., ZHELIN TOWN
- City
- FENGXIAN DISTRICT, SHANGHAI
- State
- CN-NOTA
- Postal Code
- 201416
- Country
- CN
- Correspondent
- WANG WEN - HUA
US Agent
- Business Name
- Mazza Healthcare
- Contact Name
- Amy Orrell
- Address
- 100 Tri State International Suite 125
- City
- Lincolnshire
- State
- IL
- ZIP
- 60069
- Country
- US
- [email protected]
- Phone
- 847 2823444
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2006-09-15 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2018-03-07 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2023-04-17 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-02 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2006-09-15 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2015-12-17 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2006-09-15 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2024-12-18 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-04-20 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2016-07-29 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2022-12-13 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2007-07-25 |
| Urinal | FNP | Class 1 | General Hospital | No | 2021-12-22 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2008-09-16 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2010-12-21 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2006-09-15 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2022-12-12 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2013-04-18 |
Proprietary Names
HUAYUE NON-STERILE SPECIMEN MAIL
STORAGE CONTAINER
Ice Bag
Pill Crusher Bag
Medicine Cup
Impervious Gown
HUAYUE PERSONAL HYGIENE KIT
Commode Liner
Toilet Bowl Liner
Face Mask
Protector Cast
WIPES
DISPENSER
EMESIS BAG
Urinal Bag
Patient Transfer / Repositioning Sheet
Body Bags, White
Equipment cover (Bandbags, Domebag, setup covers)
Specimen & Transport Storage Container
ABSORBENT PAD
Sponge Counter Glove
Sponge Counter Bag
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)