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STRADIS 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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
770-962-2425
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
174262477

Catalogue (3253)

Page 5 of 66
DeviceModel / ReferenceRegistriesClassStatus
Stradis 665-046
FDA UDI
Class IIActive
Stradis Medical, LLC. IN-9300CLF
FDA UDI
N/AUnknown
Stradis Medical, LLC. 570-2949
FDA UDI
Class IUnknown
Stradis 682-1493
FDA UDI
Class IIUnknown
Stradis 687-546
FDA UDI
Class IActive
Stradis 20167LBP
FDA UDI
Class IUnknown
Stradis 20031THJD
FDA UDI
Class IUnknown
Stradis 682-1797
FDA UDI
Class IIUnknown
Stradis 681-022ANL
FDA UDI
Class IUnknown
Stradis Healthcare 682-2261
FDA UDI
Class IIUnknown
Stradis Medical, LLC. MKSQ-011246A
FDA UDI
Class IIActive
Stradis Healthcare 570-2807
FDA UDI
Class IIUnknown
Stradis 690-264
FDA UDI
Class IIUnknown
Stradis Healthcare 682-001
FDA UDI
Class IIUnknown
Stradis Healthcare 40807SCP
FDA UDI
Class IUnknown
Stradis Healthcare 689-436
FDA UDI
Class IUnknown
Stradis 682-1591
FDA UDI
Class IIUnknown
Stradis Healthcare 60061WLII
FDA UDI
Class IUnknown
Stradis 609-004
FDA UDI
Class IActive
Stradis 682-937
FDA UDI
Class IIUnknown
Stradis Healthcare 570-2742
FDA UDI
Class IUnknown
Stradis Healthcare 40269PLS
FDA UDI
Class IActive
Stradis 682-1386
FDA UDI
Class IIUnknown
Stradis Healthcare 41047AHS
FDA UDI
Class IUnknown
Stradis Medical, LLC CTDC1200C
FDA UDI
Class IIActive
Stradis 682-1739
FDA UDI
Class IIUnknown
Stradis 682-935
FDA UDI
Class IIActive
Stradis Healthcare 40926TMS
FDA UDI
Class IUnknown
Stradis 682-1218
FDA UDI
Class IIUnknown
Stradis Medical, LLC. HCT222CK-3A
FDA UDI
Class IIActive
Stradis 682-925
FDA UDI
Class IIUnknown
Stradis Healthcare 570-2394
FDA UDI
Class IUnknown
Stradis Healthcare 682-296
FDA UDI
Class IIUnknown
Stradis Healthcare 570-1456
FDA UDI
Class IUnknown
Stradis Medical, LLC 100041
FDA UDI
N/AActive
Stradis 694-009
FDA UDI
Class IUnknown
Stradis Medical, LLC CD-2200
FDA UDI
N/AActive
Stradis Healthcare 681-291
FDA UDI
Class IUnknown
Stradis 682-1721
FDA UDI
Class IIActive
Stradis Medical, LLC HCT6868PA3NG0
FDA UDI
Class IIActive
Stradis 682-1963R1
FDA UDI
Class IIUnknown
Stradis 693-233R1
FDA UDI
Class IIUnknown
Stradis 682-082
FDA UDI
Class IIUnknown
Stradis 20075MWRII
FDA UDI
Class IUnknown
Stradis Healthcare 681-254
FDA UDI
Class IUnknown
Stradis 682-072
FDA UDI
Class IIActive
Stradis 40071MSS
FDA UDI
Class IUnknown
Stradis 682-1783R1
FDA UDI
Class IIUnknown
Stradis Healthcare 570-2900
FDA UDI
Class IIActive
Stradis 682-670
FDA UDI
Class IIUnknown

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