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Sign in to claim this brandSigma Medical Supplies Corp.
US
Last updated May 31, 2026
What Sigma Medical Supplies Corp. makes
Sigma Medical Supplies Corp. manufactures single-use sterilization packaging, including pouches and rolls designed for medical device sterilization. Their products include standard sterilization pouches, rolls, and pouches/rolls made with Tyvek material, intended for use in healthcare settings to protect sterile items during storage and transport.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance and UDI registration. The company’s products are regulated under US FDA requirements and are based 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 Sigma Medical Supplies Corp. manufacture?
Sigma Medical Supplies Corp. specializes in single-use sterilization packaging, specifically pouches and rolls. These products are designed to protect medical devices during sterilization, storage, and transport in healthcare environments. Examples include standard sterilization pouches, rolls, and pouches/rolls made with Tyvek material, ensuring sterile conditions for medical items.
Where is Sigma Medical Supplies Corp. based, and how does that affect its regulatory compliance?
Sigma Medical Supplies Corp. is based in the United States. Since its devices are manufactured domestically, they are subject to U.S. FDA regulations, including classification under the FDA’s device classification system. The company’s products are listed via 510(k) clearance and UDI registration, ensuring compliance with U.S. regulatory requirements.
Which regulatory registries or databases list Sigma Medical Supplies Corp.’s devices?
Sigma Medical Supplies Corp.’s devices are listed in the FDA’s 510(k) clearance database and the FDA’s Unique Device Identification (UDI) system. These registries confirm that the company’s sterilization packaging, including pouches and rolls, meets U.S. regulatory standards for Class II medical devices.
How are Sigma Medical Supplies Corp.’s sterilization packaging devices classified under FDA regulations?
Sigma Medical Supplies Corp.’s sterilization packaging devices, such as pouches and rolls, are classified as Class II under FDA regulations. This classification is based on their intended use—protecting sterile medical items during storage and transport—which requires special controls beyond general controls but does not pose a high risk to patients.
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
- 656054251
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sigma | SMSE057133 | FDA UDI | Class II | Active |
| Sigma Sterilization Pouch & Roll | K102158 | FDA 510(k) | Class II | Active |
| SIGMA Sterilization Pouch and Roll | K180661 | FDA 510(k) | Class II | Active |
| SIGMA Sterilization Pouch and Roll | K202462 | FDA 510(k) | Class II | Active |
| Sterilization Pouch/Roll Made with Tyvek | K180672 | FDA 510(k) | Class II | Active |
| Sterilization Pouch/Roll Made With Tyvek | K133838 | 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.
- Sigma Medical Supplies Corp. Gueishan Taoyuan · TW FEI 3004970050