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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 12 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions EB801PHIL
FDA UDI
Class IIActive
Aligned Medical Solutions RMS1637K
FDA UDI
Class IIActive
Aligned Medical Solutions AMS2917
FDA UDI
Class IActive
Aligned Medical Solutions PSS2166B
FDA UDI
Class IActive
Aligned Medical Solutions AMS15231
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14848
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7878
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9214
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7351
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3516D
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2819
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9035
FDA UDI
Class IActive
Aligned Medical Solutions AMS2592
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7192CS8
FDA UDI
Class IIActive
Aligned Medical Solutions 0091802
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14567
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6382
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6776A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5414
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13596A
FDA UDI
Class IActive
Aligned Medical Solutions PSS3041C
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7003A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6112A
FDA UDI
Class IActive
Aligned Medical Solutions AMS3520A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7110A
FDA UDI
Class IActive
Aligned Medical Solutions PSS1833A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11393
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11742A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9412
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15279A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8028
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5517
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3173
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16245B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6079B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6928
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16704
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6566D
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14176
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3396A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14274
FDA UDI
Class IActive
Aligned Medical Solutions AMS13545
FDA UDI
Class IActive
Aligned Medical Solutions AMS9571
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4034
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13562
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13741
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8670
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8636
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11984
FDA UDI
Class IIActive
Aligned Medical Solutions PSS1799
FDA UDI
Class IActive

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