Question 1

What types of medical devices does Darco (Europe) GmbH manufacture?

Accepted Answer

Darco (Europe) GmbH specializes in orthotic devices designed to support and stabilize joints and limbs. Their product line includes prefabricated orthotic insoles for general foot support, non-customized orthotic shoes, and a range of orthoses for the knee, ankle/foot, wrist/hand, elbow, and hip. Examples include knee supports, knee immobilizers, and knee walker braces like the Body Armor® PFA Walker. These devices are intended to aid mobility, reduce strain, or provide temporary support for musculoskeletal conditions.

Question 2

Where is Darco (Europe) GmbH based, and what does that mean for their devices?

Accepted Answer

Darco (Europe) GmbH is headquartered in the United States. This means their devices are subject to U.S. regulatory requirements, including registration in the FDA’s Unique Device Identifier (UDI) database. The company’s location also influences compliance pathways, such as the classification of their products under U.S. regulations, which determines the level of oversight and authorization required for market placement.

Question 3

Which regulatory registries list Darco (Europe) GmbH’s devices?

Accepted Answer

Darco (Europe) GmbH’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for identifying medical devices in the U.S., ensuring traceability and compliance with regulatory requirements. Listing in the UDI database is mandatory for Class I devices, which includes all of Darco’s products, as it helps track their distribution and use in clinical settings.

Question 4

How are Darco (Europe) GmbH’s devices classified under U.S. regulations?

Accepted Answer

All of Darco (Europe) GmbH’s devices fall under Class I classification in the U.S. This classification is assigned to products that pose minimal risk to patients and are generally considered safe with basic regulatory controls. Class I devices require registration with the FDA and compliance with general controls, such as proper labeling and manufacturing practices, but do not typically require pre-market approval or rigorous clinical trials. Examples like their prefabricated insoles and knee supports fit this category due to their low-risk nature.

Device	Model / Reference	Registries	Class	Status
DARCO® OrthoWedge™ Light	OW2B-STL	FDA UDI	Class I	Active
MECRON Knee Pediatric	OS203001	FDA UDI	Class I	Active
MECRON Belt B: 22 cm, U: 130-157 cm	38-7350	FDA UDI	Class I	Active
DARCO® Commodus Open	CO1	FDA UDI	Class I	Unknown
DARCO® WCS™ Light	WCSL2-L	FDA UDI	Class I	Unknown
MECRON Knee Straight L:400mm, OS:530mm, US:400mm	OS400304	FDA UDI	Class I	Active
DARCO® Relief Dual®	RD-W3	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Right	RC-M1-R	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:480mm, US:350mm	OH400100	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:450mm, US:220mm	OH600101	FDA UDI	Class I	Active
KERRAPED™ All Purpose Boot	KP2B	FDA UDI	Class I	Active
MECRON Hip-Spica U: 105-125 cm	38-820R	FDA UDI	Class I	Active
MECRON Knee 3-part 10deg	OH655131	FDA UDI	Class I	Active
DARCO® AllRound Shoe™	ARS4	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL0-L	FDA UDI	Class I	Unknown
DARCO® Puzzle Insole™	PI-WL	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL1-R	FDA UDI	Class I	Unknown
DARCO® Toe Cap	TCT1	FDA UDI	Class I	Unknown
MECRON Knee Straight L:600mm, OS:550mm, US:320mm	OS600300	FDA UDI	Class I	Active
MECRON Knee 3-part Plus	OSP655304	FDA UDI	Class I	Active
MECRON Elbow Splint Pediatric	OS030X01	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-W3-R	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 15-17 cm	OS231102	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:550mm, US:320mm	OH600301	FDA UDI	Class I	Active
MECRON Knee Straight Clinical L:400mm, OS:480mm, US:350mm	OS400204A	FDA UDI	Class I	Active
MECRON Knee Straight L:400mm, OS:430mm, US:300mm	OS400104OS	FDA UDI	Class I	Active
MECRON Torso Sonderanfertigung	S4200	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:480mm, US:350mm	OH400204OS	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI5/R	FDA UDI	Class I	Active
MECRON Knee 3-part 10deg	OH655111	FDA UDI	Class I	Active
MECRON Knee 3-part 10deg	OH655511	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 19-22 cm	OS233202	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:540mm, US:330mm	OS500302	FDA UDI	Class I	Active
DARCO® Relief Dual® Plus	RDP-M2	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:530mm, US:400mm	OH400302	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:540mm, US:330mm	OH500304	FDA UDI	Class I	Active
DARCO® Toe Cap	TCT4	FDA UDI	Class I	Unknown
DARCO® Toe Cap	TCO0	FDA UDI	Class I	Unknown
DARCO® Relief Contour Insole Left	RC-W3-L	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0 Lining	RIW2EL-1	FDA UDI	Class I	Unknown
DARCO® Toe Cap	TCDBM2	FDA UDI	Class I	Active
DARCO® Toe Cap	TCDBW2	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:540mm, US:330mm	OS500301	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-ARS3-R	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-W2-R	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL4-L	FDA UDI	Class I	Unknown
DARCO® MedSurg Pro	MS-M4	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:500mm, US:270mm	OS600201	FDA UDI	Class I	Active
Body Armor® PFA Walker Liner	BAPFAL3	FDA UDI	Class I	Active
DARCO® Toe Cap	TCT0	FDA UDI	Class I	Unknown

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