FDA Registration Active 🇨🇳 China

SOL-CARE Safety Winged Infusion Set

Reg #: 9680448 · FEI: 3003886545 · Expires 2025
Products
2
Proprietary Names
7
Establishment Types
1
Classifications
2

Registration Details

Registration Name
TIANJIN HANACO MEDICAL CO.,LTD.
Registration Number
9680448
FEI Number
3003886545
Status
Active
Expiry Year
2025
Initial Importer
No
Address
No. 129 DONGTING RD., TEDA
City
TIANJIN
Country
CN

Regulatory Submissions

510(k) Number
K163073

Owner / Operator

Firm Name
TIANJIN HANACO MEDICAL CO.,LTD.
Operator Number
9009141
Address
129 DONGTING RD., TEDA, --
City
TIANJIN
State
CN-NOTA
Postal Code
300457
Country
CN

US Agent

Business Name
MYCO Medical Supplies, Inc.
Contact Name
Sanjiv Kumar
Address
2015 Production Drive
City
Apex
State
NC
ZIP
27539
Country
US
Phone
919 4602535 ext. 105

Products

Device Name Product Code
Set, Administration, Intravascular FPA
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

Proprietary Names

SOL-CARE Safety Winged Infusion Set VACUETTE SAFETY Winged Set+Luer Adapter SOL-CARE Safety Blood Collection Needle (US market, w/needle cap) Henry Schein Safety Blood Collection Needle (w/needle cap) SOL-CARE Safety Blood Collection Needle VACUETTE SAFETY Winged Set+Holder SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)