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Terumo (Philippines) Corporation

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
—
LinkedIn
—
Facebook
—
Phone
+1(800)283-7866
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
718848773

Catalogue (220)

Page 3 of 5
DeviceModel / ReferenceRegistriesClassStatus
Surguard3 SG3-1825
FDA UDI
Class IIActive
Terumo SS+05L1
FDA UDI
Class IIActive
Surguard2 SG2+1838
FDA UDI
Class IIActive
Surguard3 SG3+2338
FDA UDI
Class IIActive
Terumo NN2522R
FDA UDI
Class IIActive
Surguard2 SG2+2516
FDA UDI
Class IIActive
Surguard3 SG3-03L2516
FDA UDI
Class IIActive
Terumo NN1838R
FDA UDI
Class IIActive
Surguard3 SG3+2138
FDA UDI
Class IIActive
Terumo NN2732R
FDA UDI
Class IIActive
Terumo SS-60L
FDA UDI
Class IIActive
Surguard3 SG3-2538
FDA UDI
Class IIActive
Surguard3 SG3+2525
FDA UDI
Class IIActive
Surguard2 SG2-2338
FDA UDI
Class IIActive
Surguard3 SG3+1916
FDA UDI
Class IIActive
Terumo SS-05L
FDA UDI
Class IIActive
Surguard2 SG2+2525
FDA UDI
Class IIActive
Surflo SR-OX2032CA
FDA UDI
Class IIActive
Surguard3 SG3-2713
FDA UDI
Class IIActive
Surguard2 SG2-01T2609
FDA UDI
Class IIActive
Surguard2 SG2+3013
FDA UDI
Class IIActive
Surguard2 SG2-2525
FDA UDI
Class IIActive
Surguard3 SG3-2038
FDA UDI
Class IIActive
Surguard3 SG3-05L2025
FDA UDI
Class IIActive
Surguard3 SG3+2051
FDA UDI
Class IIActive
Surguard2 SG2-03L2516
FDA UDI
Class IIActive
Surguard3 SG3-01T2609
FDA UDI
Class IIActive
Surflo SR-OX1851CA
FDA UDI
Class IIActive
Surguard2 SG2+2338
FDA UDI
Class IIActive
Terumo SS-10L2238
FDA UDI
Class IIActive
Terumo SS-03L2225
FDA UDI
Class IIActive
Terumo SS-03L2525
FDA UDI
Class IIActive
Terumo NN2538R
FDA UDI
Class IIActive
Surguard3 SG3-03L2138
FDA UDI
Class IIActive
Surguard2 SG2+2325
FDA UDI
Class IIActive
Terumo SS-10S
FDA UDI
Class IIActive
Surguard3 SG3-05L2138
FDA UDI
Class IIActive
Terumo NN3013R
FDA UDI
Class IIActive
Surguard2 SG2-03L2025
FDA UDI
Class IIActive
Surguard3 SG3-01T2713
FDA UDI
Class IIActive
Surguard3 SG3-03L2525
FDA UDI
Class IIActive
Terumo SS-01T2713
FDA UDI
Class IIActive
Terumo SS+10L1
FDA UDI
Class IIActive
Surguard3 SG3+1813
FDA UDI
Class IIActive
Surguard3 SG3-2525
FDA UDI
Class IIActive
Terumo SS-03L2338
FDA UDI
Class IIActive
Surguard3 SG3+2219
FDA UDI
Class IIActive
Surguard2 SG2-03L2225
FDA UDI
Class IIActive
Surguard3 SG3-03L2038
FDA UDI
Class IIActive
Surflo SR-OX1832CA
FDA UDI
Class IIActive

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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