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® PegContour™ Insole	PCI-W3-R	FDA UDI	Class I	Active
MECRON Knee Straight Comfort L:500mm, OS:490mm, US:280mm	OS500204E	FDA UDI	Class I	Active
DARCO® Relief Dual® Plus	RDP-W3	FDA UDI	Class I	Active
DARCO® PegContour™ Insole Uni	PCIU-W3	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:600mm, US:350mm	OH600404OS	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Left	RC-M3-L	FDA UDI	Class I	Active
MECRON Knee Clinical	OS955502	FDA UDI	Class I	Active
MECRON Knee Straight Comfort L:400mm, OS:430mm, US:300mm	OS400102E	FDA UDI	Class I	Active
MECRON Knee 3-part	OS20060	FDA UDI	Class I	Active
MECRON Knee Straight L:400mm, OS:480mm, US:350mm	OS400202	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Left	RC-M4-L	FDA UDI	Class I	Active
Body Armor® PFA Walker	BAPFA3	FDA UDI	Class I	Active
MECRON Knee Straight Comfort L:500mm, OS:540mm, US:330mm	OS500302E	FDA UDI	Class I	Active
MECRON Hip-Compression U: 95-115 cm	38-051	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL4-R	FDA UDI	Class I	Unknown
MECRON Knee Flexion Clinical L:500mm, OS:590mm, US:380mm	OH500404A	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 300 - 350 mm	OS030204	FDA UDI	Class I	Active
DARCO® Relief Insert™ Liner	RIL-1	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Right	RC-M2-R	FDA UDI	Class I	Active
MECRON Knee Straight L:400mm, OS:480mm, US:350mm	OS400204	FDA UDI	Class I	Active
DARCO® Body Armor® Ankle Flex	AF2	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:490mm, US:280mm	OH500201	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:490mm, US:280mm	OH500204	FDA UDI	Class I	Active
MECRON Hip-Spica U: 95-115 cm	38-720R	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-M4-R	FDA UDI	Class I	Active
DARCO® MedSurg Pro	MS-W1H	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:600mm, US:350mm	OS600404	FDA UDI	Class I	Active
MECRON Knee Pediatric	OS304001	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker Customized	RIW1C-1	FDA UDI	Class I	Active
DARCO® Toe Cap	TCT3	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 17-19 cm	OSN232204	FDA UDI	Class I	Active
DARCO® Relief Dual® + Toe Cap	C-RDTCM4	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:500mm, US:270mm	OH600200	FDA UDI	Class I	Active
MECRON Belt B: 22 cm, U: 105-127 cm	38-7340	FDA UDI	Class I	Active
MECRON Knee Pediatric	OS204001	FDA UDI	Class I	Active
DARCO® OrthoWedge™ Light	OW3B-STL	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: uber 22 cm	OS234104	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:550mm, US:320mm	OS600302	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 17-19 cm	OSN232102	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:440mm, US:230mm	OS500102	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:500mm, US:270mm	OH600202	FDA UDI	Class I	Active
DARCO® Toe Cap	TCWCS3/L	FDA UDI	Class I	Unknown
MECRON Knee 3-part 30deg	OH655334	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-ARS2-R	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:490mm, US:280mm	OS500204OS	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:450mm, US:220mm	OH600100	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:540mm, US:330mm	OS500300	FDA UDI	Class I	Active
DARCO® Body Armor® Ankle Flex	AF0	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-M3-L	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0 Achill	RIW2W-0	FDA UDI	Class I	Active

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