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 Straight L:500mm, OS:440mm, US:230mm	OS500104OS	FDA UDI	Class I	Active
MECRON® ReadyDressment Strips	MRSB500-2	FDA UDI	Class I	Unknown
MECRON Knee Flexion L:500mm, OS:490mm, US:280mm	OH500204OS	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:590mm, US:380mm	OS500404	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker Customized	RIW1C-4	FDA UDI	Class I	Active
DARCO® Posterior Splint Fix	PSF1-110	FDA UDI	Class I	Active
DARCO® Commodus Open	CO0	FDA UDI	Class I	Unknown
MECRON Knee Flexion L:500mm, OS:440mm, US:230mm	OH500101	FDA UDI	Class I	Active
MECRON Knee 3-part Plus	OHP655524	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI4/R	FDA UDI	Class I	Active
DARCO® Toe Cap	TCMM2	FDA UDI	Class I	Unknown
DARCO® WCS™ Light	WCSL3-R	FDA UDI	Class I	Unknown
MECRON Wrist Guard L: 23 cm, U: 17-19 cm	OS232204	FDA UDI	Class I	Active
DARCO® Posterior Splint	PS1-110-1	FDA UDI	Class I	Active
DARCO® TwinShoe™	TS3B	FDA UDI	Class I	Active
DARCO® Puzzle Insole™	PI-MS	FDA UDI	Class I	Active
DARCO® WCS™ / WCS™ Light Insoles	WCI2/L	FDA UDI	Class I	Active
3-teilige Universal Funktions-Knieschiene 20deg	OH30050	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:500mm, US:270mm	OS600204	FDA UDI	Class I	Active
DARCO® OrthoWedge™ Light	OW1B-STL	FDA UDI	Class I	Active
MECRON Belt B: 29 cm, U: 66-86 cm	38-7420	FDA UDI	Class I	Active
Darco® Wcs™	WCS1B/R	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-W1-R	FDA UDI	Class I	Active
DARCO® Posterior Splint	PS1-90-P1	FDA UDI	Class I	Active
DARCO® AllRound Shoe™	ARS1	FDA UDI	Class I	Active
DARCO® Wound Care Shoe System™ Insoles	WCI7	FDA UDI	Class I	Unknown
MECRON Elbow Splint Pediatric	OS030001	FDA UDI	Class I	Active
Darco® Wcs™	WCS1B/L	FDA UDI	Class I	Active
DARCO® Posterior Splint	PS2-90-P1	FDA UDI	Class I	Active
MECRON Knee Straight Comfort L:500mm, OS:540mm, US:330mm	OS500304E	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 15-17 cm	OS231202	FDA UDI	Class I	Active
DARCO® AllRound Shoe™	ARS3	FDA UDI	Class I	Active
MECRON Knee Flexion L:500mm, OS:440mm, US:230mm	OH500102	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:450mm, US:220mm	OS600104	FDA UDI	Class I	Active
MECRON Shoulder Neopren	OS102100	FDA UDI	Class I	Active
DARCO® Toe Cap	TCWCS2/L	FDA UDI	Class I	Unknown
DARCO® Relief Dual® + Toe Cap	C-RDTCW3	FDA UDI	Class I	Active
DARCO® Body Armor® Sleeve	BAS3	FDA UDI	Class I	Active
MECRON Knee Sonderanfertigung	S4100	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 400 - 500 mm	OS030404	FDA UDI	Class I	Active
DARCO® Commodus Open	CO4	FDA UDI	Class I	Unknown
DARCO® Wound Care Shoe System™	WCS4B	FDA UDI	Class I	Unknown
MECRON Knee MaBanfertigung	M4100	FDA UDI	Class I	Active
MECRON Wrist Guard L: 23 cm, U: 17-19 cm	OSN232202	FDA UDI	Class I	Active
DARCO® Toe Cap	TCDM4	FDA UDI	Class I	Unknown
MECRON Hip-Compression U: 95-115 cm	38-050	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-ARS4-L	FDA UDI	Class I	Active
MECRON Knee Straight Comfort L:500mm, OS:590mm, US:380mm	OS500404E	FDA UDI	Class I	Active
MECRON Knee 3-part	OH655324P	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker 2.0 Achill	RIW2W-3	FDA UDI	Class I	Active

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