Facility

MOTEK MEDICAL B.V.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006750942
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	Vleugelboot 14, Houten Noord-Brabant, NL 3991 CL
Registration status	Active · expires 2026
Parent company	MOTEK MEDICAL B.V. (owner-operator 9105520)
Brand names	MR Cube; RYSEN; Body Weight Support Light

Activity by year

Recalls (1)

Devices registered here (1)

Exerciser, Powered
Product code BXB (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5380

Recalls & enforcement

Class IIOngoing2019-07-29
The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

All facilities operated by MOTEK MEDICAL B.V.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MOTEK MEDICAL B.V. (FEI 3006750942) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006750942-motek-medical-b-v/

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