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MOBIUS BIONICS LLC

Last updated September 17, 2026

What MOBIUS BIONICS LLC makes

Mobius Bionics LLC manufactures myoelectric hand prostheses, including modular components and full-arm systems designed for upper-limb replacement. Their portfolio includes interchangeable hand parts and complete prosthetic arms, all tailored for myoelectric control.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Mobius Bionics LLC manufacture?

Mobius Bionics LLC specializes in myoelectric hand prostheses, which are artificial hands controlled by muscle signals. Their product line includes modular components like replaceable hand parts and full prosthetic arm systems, such as the LUKE Arm. These devices are designed to restore upper-limb function for users requiring limb replacement.

Where is Mobius Bionics LLC based?

Mobius Bionics LLC is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance, as it operates under U.S. medical device regulations.

Which regulatory registries list Mobius Bionics LLC’s devices?

Mobius Bionics LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II myoelectric prostheses, ensuring transparency in the supply chain and regulatory compliance.

How are Mobius Bionics LLC’s devices classified under U.S. regulations?

Mobius Bionics LLC’s myoelectric hand prostheses and related systems are classified as Class II devices by the FDA. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

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

Information

Country: US
Address: 286 COMMERCIAL ST, Manchester, NH, 03101
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3012481940
DUNS Number: —

Catalogue (71)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Luke Replaceable Part	LU-70339-001	FDA UDI	Class II	Active
LUKE Arm	LU-10321-0X2	FDA UDI	Class II	Active
Luke Replaceable Part	LU-38012-002	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60101-300	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60068-0500	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20283-001	FDA UDI	Class II	Active
LUKE Arm	LU-10112-002	FDA UDI	Class II	Active
Luke Replaceable Part	LU-36352-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-31072-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60072-1000	FDA UDI	Class II	Active
LUKE Arm	LU-10512-XX2	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60119-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20276-200	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60072-0500	FDA UDI	Class II	Active
LUKE Arm	LU-10322-0X2	FDA UDI	Class II	Active
Luke Replaceable Part	LU-36407-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-70154-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-41005-20060	FDA UDI	Class II	Active
Luke Replaceable Part	LU-12012-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20275-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-40176-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-40178-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60102-300	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20311-001	FDA UDI	Class II	Active
LUKE Arm	LU-10511-XX2	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20293-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20264-001	FDA UDI	Class II	Active
LUKE Arm	LU-10312-0X2	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60068-0200	FDA UDI	Class II	Active
Luke Replaceable Part	LU-70261-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20274-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20273-002	FDA UDI	Class II	Active
Luke Replaceable Part	LU-80203-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-38013-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-38035-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-38034-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-37156-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-40130-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-20269-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-70214-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-37158-001	FDA UDI	Class II	Active
LUKE Arm	LU-10122-002	FDA UDI	Class II	Active
Luke Replaceable Part	LU-12011-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60100-150	FDA UDI	Class II	Active
Luke Replaceable Part	LU-38017-001	FDA UDI	Class II	Active
LUKE Arm	LU-10521-XX2	FDA UDI	Class II	Active
LUKE Arm	LU-10522-XX2	FDA UDI	Class II	Active
Luke Replaceable Part	LU-60068-0350	FDA UDI	Class II	Active
Luke Replaceable Part	LU-36434-001	FDA UDI	Class II	Active
Luke Replaceable Part	LU-36403-001	FDA UDI	Class II	Active

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