Data / Medical devices / China / Terumo Medical Products (hangzhou) Co., Ltd.
Terumo Medical Products (hangzhou) Co., Ltd.: FDA-registered device maker in HANGZHOU Zhejiang, China, 6 510(k) clearances
Terumo Medical Products (hangzhou) Co., Ltd. is registered with the FDA (registration 3004102031) in HANGZHOU Zhejiang, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 18, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004102031
- Address
- M4-9-5,hangzhou Economic & Technological Development Zone, HANGZHOU Zhejiang, China, 310018
- Owner or operator
- Terumo Medical Products (Hangzhou) Co., LTD. (10033965)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- October 22, 2010
- Registered through
- 2027
- Brand names listed
- RADIFOCUS Torque Device, SURFLO MIDELA Securement Device, SURFLO Midela Midline Catheter, SURFLO HYBRIA Closed I.V. Catheter, SURFLO® Winged Infusion Set with Needle Protection, Surflo Winged Infusion Set, Surshield® Safety Winged Blood Collection Set, Surshield® Safety Winged Infusion Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Wire, Catheter, Neurovasculature | MOF | 2 | Manufacturer | accessdata.fda.gov |
| Midline Catheter | PND | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter, Exempt | PTL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2025 | K252402 | Midline Catheter | PND | Substantially Equivalent | Terumo Medical Products (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| December 17, 2025 | K252398 | SURFLO Hybria Closed System Safety IV Catheter | FOZ | Substantially Equivalent | Terumo Medical Products (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| June 23, 2023 | K221411 | Surflo Winged Infusion Set | FPA | Substantially Equivalent | Terumo Medical Products (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| June 29, 2022 | K220934 | RADIFOCUS Torque Device | MOF | Substantially Equivalent | Terumo Medical Products (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| May 30, 2003 | K031279 | SURSHIELD SAFETY WINGED BLOOD COLLECTION SET | FPA | Substantially Equivalent | Terumo Medical Products Hangzhou Co., Ltd. | accessdata.fda.gov |
| May 30, 2003 | K031266 | SURSHIELD SAFETY WINGED INFUSION SET | FPA | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Clamp, Vascular
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Midline Catheter
- All makers of Device, Intravascular Catheter Securement
- All makers of Guide, Wire, Catheter, Neurovasculature
Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.