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US
Last updated May 26, 2026
What Terumo (Philippines) Corporation makes
Terumo (Philippines) Corporation manufactures single-use hypodermic needles, metered-delivery hypodermic syringes, and peripheral intravenous cannulas, including products branded as SURGUARD3, SURGUARD2, SURFLO, and TERUMO.
These devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Terumo (Philippines) Corporation manufacture?
Terumo (Philippines) Corporation specializes in single-use medical devices primarily used in clinical and procedural settings. Their portfolio includes hypodermic needles designed for one-time use, metered-delivery hypodermic syringes for precise medication administration, and peripheral intravenous cannulas for fluid delivery. These devices are branded under names like SURGUARD3, SURGUARD2, SURFLO, and TERUMO, catering to needs in injection, infusion, and fluid management.
Where is Terumo (Philippines) Corporation based, and what does that mean for its regulatory oversight?
Terumo (Philippines) Corporation is based in the United States, which means its devices are subject to U.S. regulatory requirements. The company’s products fall under the jurisdiction of the FDA, ensuring compliance with standards for safety, performance, and manufacturing practices. This location also influences how the devices are classified and registered in U.S. regulatory databases.
Which regulatory registries list Terumo (Philippines) Corporation’s devices, and why does this matter?
Terumo (Philippines) Corporation’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while UDI ensures traceability and transparency in the supply chain. Listing in these registries helps healthcare providers, regulators, and distributors verify the device’s compliance and legitimacy.
How are Terumo (Philippines) Corporation’s devices classified under U.S. regulations, and what does this classification imply?
Terumo (Philippines) Corporation’s devices are classified as Class II under U.S. regulations. This classification indicates that while the devices pose moderate risk, they require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require pre-market notification (510(k)) submissions to the FDA, demonstrating that the device meets established performance standards and is substantially equivalent to a predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- terumomedical.com
- —
- —
- [email protected]
- Phone
- +1(800)283-7866
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 718848773
Catalogue (220)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surguard2 | SG2-01T2516 | FDA UDI | Class II | Active |
| Surguard2 | SG2-03L2238 | FDA UDI | Class II | Active |
| Terumo | SS-03L2516 | FDA UDI | Class II | Active |
| Terumo | SS-10L2132 | FDA UDI | Class II | Active |
| Terumo | SS-10L2125 | FDA UDI | Class II | Active |
| Terumo | SS-10L | FDA UDI | Class II | Active |
| Surguard3 | SG3-03L2325 | FDA UDI | Class II | Active |
| Terumo | SS-60C | FDA UDI | Class II | Active |
| Surguard2 | 10069495 | FDA UDI | Class II | Active |
| Surguard2 | SG2+2713 | FDA UDI | Class II | Active |
| Terumo | SS-30ES | FDA UDI | Class II | Active |
| Surguard3 | SG3+2213 | FDA UDI | Class II | Active |
| Surguard3 | SG3+2516 | FDA UDI | Class II | Active |
| Surguard2 | SG2-2138 | FDA UDI | Class II | Active |
| Terumo | NN2525R | FDA UDI | Class II | Active |
| Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety Needle | K113422 | FDA 510(k) | Class II | Active |
| Terumo(r) Needle | K121607 | FDA 510(k) | Class II | Active |
| Terumo Surguard3 Safety Needle & Hypodermic Syringe With Safety Needle | K122249 | FDA 510(k) | Class II | Active |
| Terumo SurGuard 3 Safety Hypodermic Needle | K152362 | FDA 510(k) | Class II | Active |
| Terumo Surflo I.v. Catheter | K133280 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Terumo (philippines) Corporation BINAN Laguna · PH FEI 3003902955