Vistar Medical Supplies Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 11 device types, 1 clearance.
Vistar Medical Supplies Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Suit, Surgical, Mask, Scavenging and 9 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | VISTAR MEDICAL SUPPLIES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012360512 |
| FEI number | 3012360512 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 101,201 &301, No.5 Facility, Datianyang Nansi Rd. |
| Postal code | 518105 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Disposable Blood Pressure Cuff, Air hoses,adapters, ELERA Reusable Blood Pressure Cuff-VD-001,VD-002,VD-003,VD-004,VD-005,VD-006,VD-021,VD-022,VD-023,VD-024,VD-025,VD-026 | 2015 | 50 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable Masks, KN95 Mask | 2020 | 182 |
| General Use Pneumatic Tourniquet | Class 1 | Reusable pneumatic tourniquet, Air hoses,Adapters,Protective sleeve, Tourniquet cuffs,Non-sterilized,VT-B2-34C,VT-B2-42C, Single use pneumatic tourniquet, sterile, Tourniquet cuffs,EO-sterilized,VTS-B1-8,VTS-B1-12,VTS-B1-14,VTS-B1-18,VTS-B1-18C,VTS-B1-24C,VTS-B1-30C,VTS-B1-32C, Tourniquet cuffs,Non-sterilized,VT-B1-42C,VT-B2-8,VT-B2-12,VT-B2-14,VT-B2-18,VT-B2-18C,VT-B2-24C,VT-B2-30C,VT-B2-32C and 3 more | 2019 | 5 |
| Infusor, Pressure, For I.V. Bags | Class 1 | Pressure Infusion Bag-V1005P,V1010P,V1030P, Pressure Infusion Bag-V0005P,V0010P,V0030P,V0005PD,V0010PD,V0030PD,V2005P,V2010P,V2030P,V2005PD,V2010PD,V2030PD | 2019 | 25 |
| Lung Sound Monitor | Class 2 | stethoscope | 2018 | 2 |
| Mask, Scavenging | Class 1 | disposable masks | 2020 | 158 |
| Respirator, Surgical | Class 2 | N95 mask ,KN95 mask | 2020 | 118 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | face shields, goggles | 2020 | 384 |
| Sleeve, Limb, Compressible | Class 2 | DVT Garment | 2026 | 24 |
| Suit, Surgical | Class 1 | gowns | 2020 | 74 |
| Tourniquet, Nonpneumatic | Class 1 | Emergency Tourniquet with Buckle nonpneumatic, Outdoor Emergency First Aid Tourniquet Non pneumatic, Disposable strapping tourniquet non pneumatic, Air hoses,Adapters,Protective sleeve | 2022 | 124 |
Clearances
1 clearance names Vistar Medical Supplies Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253386 | 2026-06-25 | JOW | Traditional | This company |
| K152465 | 2015-10-29 | DXQ | Traditional | Shenzhen Vistar Medical Supplies Co., Ltd. |
| K152468 | 2015-10-29 | DXQ | Traditional | Shenzhen Vistar Medical Supplies Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | NIBP cuffs (disposable), NIBP cuffs (reusable), ABI cuffs, Tourniquet cuffs, Pressure infusion bags |
| OEM and ODM | Offered |
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.
The manufacturer named here can complete this record.