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Sign in to claim this brandSurgyco LLC
US
Last updated May 23, 2026
What Surgyco LLC makes
Surgyco LLC manufactures single-use general-purpose syringes designed for medical and clinical applications. These devices are intended for precise fluid administration, including injections, infusions, and sample collection in various healthcare settings.
The company’s syringes are classified under FDA device classes I and II, with some falling under the unclassified (U) category. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance in 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 Surgyco LLC manufacture?
Surgyco LLC specializes in single-use general-purpose syringes. These devices are designed for medical and clinical use, such as administering injections, infusions, or collecting samples in healthcare settings. The focus is on precision and reliability for fluid handling.
Where is Surgyco LLC based?
Surgyco LLC is based in the United States. The company’s operations and manufacturing are centered within the country, aligning with regulatory requirements for medical device production.
Which regulatory registries or databases list Surgyco LLC’s devices?
Surgyco LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for traceability, compliance, and transparency in the medical device supply chain.
How are Surgyco LLC’s syringes classified under FDA regulations?
Surgyco LLC’s syringes fall into different FDA device classes depending on their design and intended use. Most are classified as Class I (low-risk, general controls), some as Class II (moderate-risk, requiring special controls), and a few are unclassified (U). Classification is determined by factors like the syringe’s purpose, materials, and potential risks.
Why are Surgyco LLC’s syringes listed in the FDA’s UDI database?
The FDA’s Unique Device Identifier (UDI) database ensures that each syringe has a unique, machine-readable identifier. This helps track devices throughout their lifecycle, supports regulatory compliance, and improves patient safety by reducing errors in device identification and recall processes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 118768538
Catalogue (261)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surgyco | SS010235 | FDA UDI | Class II | Active |
| Surgyco | PSS10135 | FDA UDI | Class I | Active |
| Surgyco | SRN02240 | FDA UDI | Class II | Active |
| Surgyco | GS000300 | FDA UDI | Class I | Active |
| Surgyco | PS010240 | FDA UDI | Class I | Active |
| Surgyco | SR030220 | FDA UDI | Class II | Active |
| Surgyco | SSSB0015 | FDA UDI | Class I | Active |
| Surgyco | GS000055 | FDA UDI | Class I | Active |
| Surgyco | GS000397 | FDA UDI | Class I | Active |
| Surgyco | GS001510 | FDA UDI | Class I | Active |
| Surgyco | GS000700 | FDA UDI | Class I | Active |
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