Medstar Healthcare Co., Limited
Registered establishment in Huzhou, Zhejiang, China. 13 device types, 2 clearances.
Medstar Healthcare Co., Limited is a manufacturer holding a current FDA establishment registration. The registration covers Sling, Arm, Cover, Limb and 11 other device types. Its earliest product listing with the FDA dates from 2017.
13device types registered with the FDA
2510(k) clearances
Registration
| Registered name | MEDSTAR HEALTHCARE CO.,LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014108257 |
| FEI number | 3014108257 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 美鑫醫療保健有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Huzhou |
|---|---|
| Province | Zhejiang |
| Address | DIPU INDUSTRIAL ZONE, ANJI COUNTY, HUZHOU CITY,ZHEJIANG,CHINA |
| Postal code | 313300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | breathing mask | 2020 | 439 |
| Bandage, Cast | Class 1 | Bandage, Cast (Polymer And Fiberglass Casting Bandage) | 2017 | 81 |
| Bandage, Elastic | Class 1 | Cohesive bandage, Conforming(Pbt) Bandage, Pop, Gauze Bandage, Pressure Bandage, Cold Bandage), Bandage, Elastic (Elastic Bandage, Crepe Bandage, | 2017 | 280 |
| Bedding, Disposable, Medical | Class 1 | Rescue Blankets | 2019 | 308 |
| Component, Cast | Class 1 | Component, Cast (Under cast padding, Orthopedic cast padding) | 2017 | 22 |
| Cover, Limb | Class 1 | Cover, Limb (Stockinette, Tubular bandage) | 2017 | 24 |
| Disinfectant, Medical Devices | Class 1 | Alcohol pad | 2017 | 197 |
| Dressing, Wound, Hydrophilic | Class 1 | Dressing,Wound,Hydrophilic (Non-Adhesive Dressing (Pad) , Eye Pad) | 2017 | 195 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | gauze pad,gauze swab,gauze sponge | 2020 | 266 |
| Respirator, Surgical | Class 2 | Disposable surgical face mask, Protective mask | 2020 | 118 |
| Sling, Arm | Class 1 | triangle bandage | 2019 | 126 |
| Tape And Bandage, Adhesive | Class 1 | Tape | 2019 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet, Nonpneumatic (Tourniquet) | 2017 | 124 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K921612 | 1992-08-18 | LIH | Traditional | This company |
| K880548 | 1988-09-29 | JOJ | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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