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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 26 of 108
DeviceModel / ReferenceRegistriesClassStatus
Aligned Medical Solutions AMS12356A
FDA UDI
Class IActive
Aligned Medical Solutions PSS3085
FDA UDI
Class IIActive
Aligned Medical Solutions AMS16703
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5528C
FDA UDI
Class IActive
Aligned Medical Solutions AMS12394B
FDA UDI
Class IIActive
Aligned Medical Solutions CCR60046
FDA UDI
Class IIActive
Aligned Medical Solutions AMS5451D
FDA UDI
Class IActive
Aligned Medical Solutions AMS15057A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS1721
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13760
FDA UDI
Class IIActive
Aligned Medical Solutions AMS6271B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7427A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS10817
FDA UDI
Class IActive
Aligned Medical Solutions RMS1780
FDA UDI
Class IIActive
Aligned Medical Solutions PSS1931A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14155
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11840
FDA UDI
Class IActive
Aligned Medical Solutions AMS4914A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9575
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9494
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14567A
FDA UDI
Class IActive
Aligned Medical Solutions AMS7106
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12396A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14260
FDA UDI
Class IIActive
Aligned Medical Solutions AMS7535A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS8937
FDA UDI
Class IActive
Aligned Medical Solutions AMS14528A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS9701B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS14440
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11844A
FDA UDI
Class IActive
Aligned Medical Solutions AMS13762
FDA UDI
Class IIActive
Aligned Medical Solutions AMS15544
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11780B
FDA UDI
Class IIActive
Aligned Medical Solutions AMS3388A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS12780
FDA UDI
Class IIActive
Aligned Medical Solutions PSS1745A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13429
FDA UDI
Class IActive
Aligned Medical Solutions AMS12760A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS4693A
FDA UDI
Class IActive
Aligned Medical Solutions PSS3518B
FDA UDI
Class IIActive
Aligned Medical Solutions PSS2295A
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11639
FDA UDI
Class IIActive
Aligned Medical Solutions CAT1461DCI
FDA UDI
Class IIActive
Aligned Medical Solutions PSS3422E
FDA UDI
Class IActive
Aligned Medical Solutions AMS9041CP
FDA UDI
Class IIActive
Aligned Medical Solutions 00107210
FDA UDI
Class IIActive
Aligned Medical Solutions AMS13146
FDA UDI
Class IActive
Aligned Medical Solutions AMS12093
FDA UDI
Class IIActive
Aligned Medical Solutions AMS11852
FDA UDI
Class IActive
Aligned Medical Solutions AMS13732
FDA UDI
Class IIActive

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