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Point Designs, Inc.

United States US-MF-000013587 Last updated 17 Sep 2026

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Devices
33
Registries
EUDAMED
FDA recalls
0

Catalogue33

About

From clinicians advancing patient care to individuals looking for a device they can rely on, Point Designs is here to guide and support you every step of the way.

From the manufacturer's own website. Source

What Point Designs, Inc. makes

Point Designs, Inc. manufactures modular mounting systems and digital input devices, including the Point Pivot+, Point Partial, and Point Digit series in various lengths (e.g., 55mm, 60mm, 70mm, 95mm). These products include standalone units and mounting kits for right-hand or thumb use, primarily designed for medical and assistive applications.

The company’s products are classified as Class I medical devices and are listed in the EU’s eudamed registry. Point Designs, Inc. 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 Point Designs, Inc. manufacture?

Point Designs, Inc. specializes in modular mounting systems and digital input devices. Their product line includes the Point Pivot+, Point Partial, and Point Digit series, available in various lengths (e.g., 55mm, 60mm, 70mm, 95mm). These devices also come with mounting kits designed for right-hand or thumb use, catering to medical and assistive applications.

Where is Point Designs, Inc. based?

Point Designs, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly for manufacturers based in the U.S.

Are Point Designs’ devices listed in any regulatory registries?

Yes, Point Designs’ devices are listed in the EU’s eudamed registry. This database tracks medical devices authorized for sale within the European Economic Area, ensuring transparency and traceability for regulatory oversight.

How are Point Designs’ devices classified under medical device regulations?

Point Designs’ products are classified as Class I medical devices. This classification is typically assigned to low-risk devices that pose minimal risk to patients and users, such as certain assistive or mounting systems. The classification determines regulatory requirements, including labeling, manufacturing standards, and post-market surveillance.

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

Information

Country
United States
Address
2100, W 6th Ave, Broomfield, United States
Phone
+1 720 600 4753
PRRC contact
Levin Sliker
EUDAMED SRN
US-MF-000013587