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® Wcs™	WCS5B/L	FDA UDI	Class I	Active
MECRON Knee 3-part	OS655101	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:590mm, US:380mm	OH500404	FDA UDI	Class I	Active
DARCO® Toe Cap	TCW2	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 15-17 cm	OS231204	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:600mm, US:350mm	OS600402	FDA UDI	Class I	Active
MECRON Hip-Compression U: 105-125 cm	38-052	FDA UDI	Class I	Active
DARCO® Toe Cap	TCMW3	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 15-17 cm	OSN231204	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI4/L	FDA UDI	Class I	Active
DARCO® Toe Cap	TCMM4	FDA UDI	Class I	Unknown
DARCO® TAS™ (Toe Alignment Splint)	TAS-22	FDA UDI	Class I	Active
DARCO® PegContour™ Insole Uni	PCIU-M1	FDA UDI	Class I	Active
DARCO® Body Armor® Ankle Flex	AF3	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-ARS2-L	FDA UDI	Class I	Active
KERRAPED™ All Purpose Boot	KP3B	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 15-17 cm	OSN231202	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 350 - 400 mm	OS030304	FDA UDI	Class I	Active
DARCO® Puzzle Insole™	PI-ML	FDA UDI	Class I	Active
DARCO® Toe Cap	TCMM3	FDA UDI	Class I	Unknown
DARCO® PegContour™ Insole Uni	PCIU-M3	FDA UDI	Class I	Active
DARCO® Toe Cap	TCWCS0/R	FDA UDI	Class I	Unknown
DARCO® Relief Contour Insole Right	RC-W3-R	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:430mm, US:300mm	OH400102	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-M3-R	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-M1-L	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Right	RC-W1-R	FDA UDI	Class I	Active
DARCO® Body Armor® Pro Term Liner	BAPTL3	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0	RIW2-2	FDA UDI	Class I	Active
DARCO® Toe Cap	TCDW1	FDA UDI	Class I	Unknown
MECRON Knee Straight L:500mm, OS:540mm, US:330mm	OS500304	FDA UDI	Class I	Active
MECRON Knee 3-part	OS20040	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:450mm, US:220mm	OH600104	FDA UDI	Class I	Active
Darco® Wcs™	WCS3B/L	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 19-22 cm	OSN233102	FDA UDI	Class I	Active
DARCO® Posterior Splint	PS3-90-P1	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:490mm, US:280mm	OH500202	FDA UDI	Class I	Active
DARCO® Toe Cap	TCWCS4/L	FDA UDI	Class I	Unknown
DARCO® Wound Care Shoe System™	WCS3B	FDA UDI	Class I	Unknown
DARCO® Relief Insert™ Walker 2.0	RIW2-3	FDA UDI	Class I	Active
MECRON Knee Flexion Clinical L:500mm, OS:440mm, US:230mm	OH500104A	FDA UDI	Class I	Active
KERRAPED™ All Purpose Boot	KP4B	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI3/L	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 250 - 300 mm	OS030104	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0	RIW2-0	FDA UDI	Class I	Active
DARCO® Relief Dual®	RD-BM1	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:480mm, US:350mm	OH400104OS	FDA UDI	Class I	Active
DARCO® Toe Cap	TCW3	FDA UDI	Class I	Unknown
MECRON Knee 3-part 30deg	OH655331	FDA UDI	Class I	Active
Darco® Wcs™	WCS5B/R	FDA UDI	Class I	Active

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