Tianjin Hanaco Medical Co., Ltd.
Registered establishment in Tianjin, China. 3 device types.
Tianjin Hanaco Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Set, Administration, Intravascular, Needle, Conduction, Anesthetic (W/Wo Introducer) and 1 other device type. Its earliest product listing with the FDA dates from 2012.
Registration
| Registered name | TIANJIN HANACO MEDICAL CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9680448 |
| FEI number | 3003886545 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No. 129 DONGTING RD., TEDA |
| Postal code | 300457 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Needle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | Phoenix | 2012 | 9 |
| Set, Administration, Intravascular | Class 2 | VACUETTE SAFETY Winged Set+Holder, SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder, Henry Schein Safety Blood Collection Needle (w/needle cap), SOL-CARE Safety Blood Collection Needle, VACUETTE SAFETY Winged Set+Luer Adapter, SOL-CARE Safety Winged Infusion Set and 1 more | 2018 | 49 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | VACUETTE SAFETY Winged Set+Holder, SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder, Henry Schein Safety Blood Collection Needle (w/needle cap), SOL-CARE Safety Blood Collection Needle, VACUETTE SAFETY Winged Set+Luer Adapter, SOL-CARE Safety Winged Infusion Set and 1 more | 2018 | 23 |
Clearances
No clearance names Tianjin Hanaco Medical Co., Ltd. as applicant. One is 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 |
|---|---|---|---|---|
| K990519 | 2000-06-02 | BSP | Traditional | Myco Medical Supplies, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1986 |
|---|---|
| Main products | Insulin injection needles, Guidewires, Vascular catheter kits, Anesthesia needles, Infusion apparatus |
| Certifications | ISO9002, ISO13488, EN46002 |
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.