FDA Registration
Active
🇨🇳 China
SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. CO., LTD.
Reg #: 3008729549
·
FEI: 3008729549
·
Expires 2026
Products
25
Proprietary Names
10
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. CO., LTD.
- Registration Number
- 3008729549
- FEI Number
- 3008729549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17 Floor, No. 757 Guangfu Rd.
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K101468
Owner / Operator
- Firm Name
- Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd.
- Operator Number
- 10034056
- Address
- 158 Han Zhong Road, 15Floor
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200070
- 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 |
|---|---|---|---|---|---|
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2023-03-20 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2011-01-07 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2014-10-28 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2011-01-07 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2023-02-07 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2011-01-07 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-02-07 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2013-10-24 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2011-01-07 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2020-11-03 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2014-10-28 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2014-11-10 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2011-01-07 |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | Class 2 | Gastroenterology, Urology | No | 2011-01-06 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2015-01-28 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2014-10-28 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2023-02-07 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-01-31 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2011-01-07 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2011-01-07 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2023-02-07 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2016-10-12 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2013-10-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2014-10-28 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2021-03-02 |
Proprietary Names
Chair, Adjustable, Mechanical
Table, Mechanical
Pad, Heating, Powered
STEP DOWN TIP
Coverslips, Microscope Slide
PLASTIC MASSAGE TOOL
Therapeutic, Electric
Needle, Hypodermic, Single Lumen
DISPOSABLE MOUTH MIRROR
Container, Specimen Mailer And Storage, Non-Sterile
Establishment Types
Export Device to the United States But Perform No Other Operation on Device