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Aligned Medical Solutions

US

Last updated May 24, 2026

What Aligned Medical Solutions makes

Aligned Medical Solutions manufactures single-use surgical procedure kits for general surgery, orthopaedics, ophthalmology, obstetrics/gynaecology, and ENT, as well as medicated general surgical kits. Their portfolio also includes angiography kits and non-medicated epidural anaesthesia sets, designed for procedural use in clinical settings.

These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable US regulatory requirements for medical devices.

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 Aligned Medical Solutions primarily manufacture?

Aligned Medical Solutions specializes in single-use surgical procedure kits across multiple specialties, including general surgery, orthopaedics, ophthalmology, obstetrics/gynaecology, and ENT. Their portfolio also includes medicated general surgical kits, angiography kits, and non-medicated epidural anaesthesia sets. These devices are designed for procedural use in clinical environments, ensuring compatibility with various surgical needs.

Where is Aligned Medical Solutions based, and what regulatory framework does it follow?

Aligned Medical Solutions is based in the United States. As a US-based manufacturer, its devices must comply with applicable US regulatory requirements for medical devices, including those set by the FDA. The company’s products are developed and marketed within this regulatory environment.

Which regulatory registries list Aligned Medical Solutions’ devices?

Aligned Medical Solutions’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the US market, allowing healthcare providers and regulators to access critical information about the devices.

How are Aligned Medical Solutions’ devices classified under FDA regulations?

Aligned Medical Solutions’ devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part involved.

What distinguishes Aligned Medical Solutions’ medicated surgical kits from their non-medicated counterparts?

Aligned Medical Solutions offers both medicated and non-medicated surgical kits, with the key difference being the inclusion of pharmaceutical agents in the medicated versions. Medicated kits are designed to deliver specific therapeutic substances during surgery, such as antimicrobials or other agents to support healing or reduce infection risk, whereas non-medicated kits provide sterile tools and materials without additional pharmaceutical components.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
+1(888)637-7056
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
106580145

Catalogue (5375)

Page 19 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS3460
FDA UDI
Class IActive
Aligned Medical Solutions AMS14562A
FDA UDI
Class IIActive
Aligned Medical Solutions PRO90131
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14736
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12914
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11742
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6370A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15080
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6818A
FDA UDI
Class IActive
Aligned Medical Solutions NGSCT-1
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8240B
FDA UDI
Class IIActive
Aligned Medical Solutions PRO6021
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4417C
FDA UDI
Class IActive
Aligned Medical Solutions AMS13272
FDA UDI
Class IIActive
Aligned Medical Solutions 0068774
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12947
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14375A
FDA UDI
Class IActive
Aligned Medical Solutions AMS8655
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6035
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12474C
FDA UDI
Class IActive
Aligned Medical Solutions AMS12385B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13744
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16191
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10874C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6561F
FDA UDI
Class IActive
Aligned Medical Solutions AMS2037A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7276A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9768
FDA UDI
Class IActive
Aligned Medical Solutions VPP1018
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5240
FDA UDI
Class IActive
Aligned Medical Solutions AMS6571A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16810
FDA UDI
Class IActive
Aligned Medical Solutions AMS16091A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15325C
FDA UDI
Class IActive
Aligned Medical Solutions AMS16156
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14346
FDA UDI
Class IActive
Aligned Medical Solutions CCR60025
FDA UDI
Class IActive
Aligned Medical Solutions AMS3327D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12622
FDA UDI
Class IIActive
Aligned Medical Solutions PRO6012
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15410
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9479
FDA UDI
Class IActive
Aligned Medical Solutions PSS1844B
FDA UDI
Class IActive
Aligned Medical Solutions VPP1009
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12932
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12355
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10816
FDA UDI
Class IIActive
Aligned Medical Solutions 001072-12
FDA UDI
Class IIActive
Aligned Medical Solutions WD51846
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15045
FDA UDI
Class IIActive

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