Facility

VISGENEER, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst OAI

—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)	3005644014
Establishment type	Repack or Relabel Medical Device
Location	NO. 335, SEC. 6 HSINCHU CITY Hsinchu(City), TW 30094
Registration status	Active · expires 2026
Parent company	VISGENEER, INC. (owner-operator 9084502)
Brand names	eBmonitor eBchek

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Product code QRK (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4850
Multiple Use Blood Lancet For Single Patient Use Only
Product code QRL (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4850

Recalls & enforcement

Class IIOngoing2023-10-04
Due to products distributed without premarket clearance or approvals.

FDA inspections (1)

OAI2025-02-27
Official Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by VISGENEER, INC.

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. “VISGENEER, INC. (FEI 3005644014) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005644014-visgeneer-inc/

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