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Sign in to claim this brandSTRADIS MEDICAL, LLC
US
Last updated May 25, 2026
What STRADIS MEDICAL, LLC makes
The company produces single-use surgical procedure kits, including both medicated and non-medicated variants for general surgical applications. It also supplies peripheral intravenous catheterization support kits, wound dressing kits (medicated and non-medicated), and vascular catheterization/maintenance kits. Additionally, it manufactures reusable compression/pressure socks and single-use general-purpose syringes.
These products are regulated under FDA’s classification system as Class I, Class II, or Unclassified devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is 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 Stradis Medical, LLC primarily manufacture?
Stradis Medical, LLC specializes in a range of medical devices, including single-use surgical procedure kits (both medicated and non-medicated), peripheral intravenous catheterization support kits, wound dressing kits (medicated and non-medicated), vascular catheterization/maintenance kits (non-medicated), reusable compression/pressure socks, and single-use general-purpose syringes. These products are designed for general surgical, wound care, and vascular applications.
Where is Stradis Medical, LLC based, and how does that affect its regulatory oversight?
Stradis Medical, LLC is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA classifies its products as Class I, Class II, or Unclassified devices, depending on their risk level and intended use. This classification determines the regulatory pathway and requirements for market authorization.
Are Stradis Medical, LLC’s devices listed in any regulatory databases, and why does this matter?
Yes, Stradis Medical, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and efficient tracking of medical devices throughout their lifecycle. It helps healthcare providers, regulators, and manufacturers identify specific devices, verify compliance, and manage recalls or post-market surveillance effectively.
How are Stradis Medical, LLC’s devices classified by the FDA, and what does that classification mean?
Stradis Medical, LLC’s devices are classified by the FDA as Class I, Class II, or Unclassified. Class I devices generally pose the lowest risk and may require general controls (e.g., good manufacturing practices) for authorization. Class II devices involve moderate risk and may require special controls (e.g., performance standards or post-market surveillance) in addition to general controls. Unclassified devices are those not yet assigned a risk category and may undergo a classification review process to determine their regulatory pathway.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- stradishealthcare.com
- —
- —
- [email protected]
- Phone
- 770-962-2425
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 174262477
Catalogue (3253)
Page 2 of 66| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stradis | 681-265 | FDA UDI | Class I | Unknown |
| Stradis | 681-501R1 | FDA UDI | Class I | Unknown |
| Stradis | 682-1230 | FDA UDI | Class II | Unknown |
| Stradis Medical, LLC. | 525-019 | FDA UDI | Class II | Active |
| Stradis Healthcare | 570-2271 | FDA UDI | Class I | Unknown |
| Stradis | 41022NMP | FDA UDI | Class I | Active |
| Stradis | 40771GPS | FDA UDI | Class I | Unknown |
| Stradis | 682-642 | FDA UDI | Class II | Unknown |
| Stradis Medical, LLC. | F5PG013.01 | FDA UDI | Class I | Active |
| Stradis | 693-233 | FDA UDI | Class II | Unknown |
| Stradis | 682-030 | FDA UDI | Class II | Unknown |
| Stradis Healthcare | 570-2673 | FDA UDI | Class II | Unknown |
| Stradis Healthcare | 570-2680 | FDA UDI | Class II | Active |
| Stradis | 525-165 | FDA UDI | Class I | Unknown |
| Stradis | 682-1540 | FDA UDI | Class II | Unknown |
| Stradis Healthcare | 682-2342 | FDA UDI | Class II | Unknown |
| Stradis Healthcare | 40208AMS | FDA UDI | Class I | Unknown |
| Stradis Healthcare | 570-2743 | FDA UDI | Class II | Unknown |
| Stradis | 682-1402 | FDA UDI | Class II | Active |
| Stradis Healthcare | 570-3219 | FDA UDI | Class II | Active |
| Stradis | 570-3152 | FDA UDI | Class II | Unknown |
| Stradis | 40422LSP | FDA UDI | Class I | Active |
| Stradis Healthcare | 682-824R1 | FDA UDI | Class II | Unknown |
| Stradis | 40280OSA | FDA UDI | Class I | Unknown |
| Stradis | 20043GDP | FDA UDI | Class I | Unknown |
| Stradis Healthcare | 682-244 R5 | FDA UDI | Class I | Active |
| stradis | 681-506 | FDA UDI | Class I | Unknown |
| Stradis Healthcare | 694-009 | FDA UDI | Class II | Unknown |
| Stradis | 682-2319 | FDA UDI | Class II | Unknown |
| Stradis Healthcare | 40580DFS | FDA UDI | Class I | Unknown |
| Stradis Medical, LLC. | HCT9849-1 | FDA UDI | Class II | Active |
| Stradis | 682-098 | FDA UDI | Class II | Active |
| Stradis Healthcare | 686-126 | FDA UDI | Class II | Unknown |
| Stradis Medical, LLC. | F5PG014.01 | FDA UDI | Class I | Unknown |
| Stradis Medical, LLC | DC8903CP-2 | FDA UDI | Class II | Active |
| Stradis Medical, LLC. | DC-5073C | FDA UDI | N/A | Unknown |
| Stradis | 682-402 | FDA UDI | Class II | Active |
| Stradis Healthcare | 682-1267 | FDA UDI | Class II | Unknown |
| Stradis | ORALSURG | FDA UDI | Class I | Unknown |
| Stradis | 525-073 | FDA UDI | Class II | Unknown |
| Stradis Medical, LLC | DCT-9158 | FDA UDI | N/A | Unknown |
| Stradis Healthcare | 40844HCPI | FDA UDI | Class I | Unknown |
| Stradis | 682-1598 | FDA UDI | Class II | Unknown |
| Stradis | 20256RBHC | FDA UDI | Class I | Unknown |
| Stradis | 682-1752 | FDA UDI | Class II | Unknown |
| Stradis | ZZ 1409 | FDA UDI | Class I | Active |
| Stradis | 682-1643 | FDA UDI | Class II | Active |
| Stradis Healthcare | 682-1473 | FDA UDI | Class II | Unknown |
| Stradis Healthcare | 570-2890 | FDA UDI | N/A | Active |
| Stradis | 40093DGS | FDA UDI | Class I | Active |
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