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® Wound Care Shoe System™	WCC3B	FDA UDI	Class I	Unknown
DARCO® Wound Care Shoe System™ Insoles	WCI2	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 17-19 cm	OS232202	FDA UDI	Class I	Active
DARCO® Posterior Splint	PS3-110-1	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-M2-L	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI7/R	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: uber 22 cm	OS234204	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:540mm, US:330mm	OH500300	FDA UDI	Class I	Active
MECRON Knee Straight L:400mm, OS:530mm, US:400mm	OS400304OS	FDA UDI	Class I	Active
MECRON Knee Straight Comfort L:500mm, OS:590mm, US:380mm	OS500402E	FDA UDI	Class I	Active
MECRON Knee 3-part	OS655304	FDA UDI	Class I	Active
DARCO® Toe Cap	TCM2	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 19-22 cm	OS233204	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 19-22 cm	OSN233204	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI5/L	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:590mm, US:380mm	OH500400	FDA UDI	Class I	Active
DARCO® Toe Cap	TCM4	FDA UDI	Class I	Unknown
Darco® Wcs™	WCS2B/R	FDA UDI	Class I	Active
DARCO® Puzzle Insole™	PI-MM	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL3-L	FDA UDI	Class I	Unknown
DARCO® Relief Insert™ Walker Customized	RIW1C-2	FDA UDI	Class I	Active
DARCO® TwinShoe™	TS4B	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: uber 22 cm	OSN234204	FDA UDI	Class I	Active
DARCO® Toe Cap	TCO3	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 19-22 cm	OSN233202	FDA UDI	Class I	Active
MECRON Knee Pediatric	OS202001	FDA UDI	Class I	Active
MECRON Knee Pediatric	OS303001	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0	RIW2-4	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 17-19 cm	OSN232104	FDA UDI	Class I	Active
DARCO® Relief Dual® + Toe Cap	C-RDTCM1	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:590mm, US:380mm	OS500402	FDA UDI	Class I	Active
DARCO® Toe Cap	TCDM3	FDA UDI	Class I	Unknown
DARCO® WCS™ / WCS™ Light Insoles	WCI1/R	FDA UDI	Class I	Active
DARCO® PegContour™ Insole Uni	PCIU-ARS5	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:550mm, US:320mm	OH600300	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:600mm, US:350mm	OS600400	FDA UDI	Class I	Active
MECRON Knee 3-part	OH655521	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:590mm, US:380mm	OH500402	FDA UDI	Class I	Active
DARCO® Puzzle Insole™	PI-MXL	FDA UDI	Class I	Active
DARCO® PegContour™ Insole Uni	PCIU-ARS3	FDA UDI	Class I	Active
MECRON® ReadyDressment Strips	MRSB-2	FDA UDI	Class I	Unknown
MECRON Shoulder-Hand MaBanfertigung	M4300	FDA UDI	Class I	Active
MECRON Hip-Spica U: 105-125 cm	38-820L	FDA UDI	Class I	Active
DARCO® Posterior Splint Plus Fix	PSF2-90-P	FDA UDI	Class I	Active
DARCO® MedSurg Pro	MS-W3	FDA UDI	Class I	Active
DARCO® Body Armor® Heel Reliever	BAHR-F	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL1-L	FDA UDI	Class I	Unknown
MECRON Knee Flexion L:400mm, OS:430mm, US:300mm	OH400101	FDA UDI	Class I	Active
DARCO® MedSurg Pro®	MS-M1	FDA UDI	Class I	Active
DARCO® Toe Cap	TCDW2	FDA UDI	Class I	Unknown

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