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
MECRON Knee Flexion L:600mm, OS:600mm, US:350mm	OH600400	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: uber 22 cm	OS234102	FDA UDI	Class I	Active
DARCO® Wound Care Shoe System™ Insoles	WCI3	FDA UDI	Class I	Unknown
Darco® Wcs™	WCS3B/R	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0 Achill	RIW2W-2	FDA UDI	Class I	Active
DARCO® Body Armor® Sleeve	BAS2	FDA UDI	Class I	Active
MECRON Knee Flexion 10deg L:500mm, OS:590mm, US:380mm	OH500404S	FDA UDI	Class I	Active
DARCO® TwinShoe™	TS0B	FDA UDI	Class I	Active
DARCO® Commodus Open	CO3	FDA UDI	Class I	Unknown
DARCO® Body Armor® Stirrup Acute	BASAB-2	FDA UDI	Class I	Active
MECRON Knee Flexion 10deg L:500mm, OS:490mm, US:280mm	OH500204S	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:600mm, US:350mm	OS600401	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI1/L	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:450mm, US:220mm	OS600104OS	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 15-17 cm	OSN231102	FDA UDI	Class I	Active
DARCO® Wound Care Shoe System™	WCS0B	FDA UDI	Class I	Unknown
MECRON Knee Straight L:600mm, OS:500mm, US:270mm	OS600200	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 300 - 350 mm	OS030202	FDA UDI	Class I	Active
DARCO® MedSurg Pro	MS-W2H	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:450mm, US:220mm	OS600102	FDA UDI	Class I	Active
MECRON® ReadyDressment Strips	MRSB500-1	FDA UDI	Class I	Unknown
DARCO® Wound Care Shoe System™ Insoles	WCI4	FDA UDI	Class I	Unknown
MECRON Knee Flexion L:600mm, OS:600mm, US:350mm	OH600404	FDA UDI	Class I	Active
DARCO® Wound Care Shoe System™	WCS1B	FDA UDI	Class I	Unknown
DARCO® AllRound Shoe™	ARS0	FDA UDI	Class I	Active
DARCO® Toe Cap	TCW1	FDA UDI	Class I	Unknown
MECRON Knee Flexion L:400mm, OS:530mm, US:400mm	OH400304OS	FDA UDI	Class I	Active
KERRAPED PLUS™ All Purpose Boot	KPP3	FDA UDI	Class I	Active
DARCO® Body Armor® Pro Term Liner	BAPTL2	FDA UDI	Class I	Active
DARCO® MedSurg Pro	MS-W1	FDA UDI	Class I	Active
DARCO® Posterior Splint	PS2-90-1	FDA UDI	Class I	Active
DARCO® OrthoWedge™ Light	OW4B-STL	FDA UDI	Class I	Active
Darco® Wcs™	WCS4B/L	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:480mm, US:350mm	OH400202	FDA UDI	Class I	Active
KERRAPED PLUS™ All Purpose Boot	KPP2	FDA UDI	Class I	Active
MECRON Knee Straight L:400mm, OS:430mm, US:300mm	OS400101	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Left	RC-W2-L	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:540mm, US:330mm	OS500304OS	FDA UDI	Class I	Active
MECRON Knee 3-part	OS655504	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL0-R	FDA UDI	Class I	Unknown
DARCO® PegContour™ Insole	PCI-M3-R	FDA UDI	Class I	Active
DARCO® Toe Cap	TCT2	FDA UDI	Class I	Unknown
MECRON Knee 3-part	OS20050	FDA UDI	Class I	Active
DARCO® Relief Insert™ Liner	RIL-2	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:540mm, US:330mm	OH500301	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 19-22 cm	OSN233104	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 400 - 500 mm	OS030402	FDA UDI	Class I	Active
DARCO® MedSurg Pro®	MS-M2H	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-W1-L	FDA UDI	Class I	Active
DARCO® Toe Cap	TCWCS3/R	FDA UDI	Class I	Unknown

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