Facility

M.E.Nikkiso Vietnam Co., Ltd.

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)	3027859369
Establishment type	Manufacture Medical Device
Location	No.8, Road No.7, Viet Nam Singapore Industrial Park, Tho Phong Commune Quang Ngai, VN 57000
Registration status	Active · expires 2026
Parent company	NIKKISO CO., LTD. (owner-operator 8031561)
Brand names	C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series; AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)

Activity by year

Recalls (1)

Devices registered here (1)

Accessories, Blood Circuit, Hemodialysis
Product code KOC (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5820

Recalls & enforcement

Class IIOngoing2021-11-24
Device lacks premarket approval.

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. “M.E.Nikkiso Vietnam Co., Ltd. (FEI 3027859369) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027859369-m-e-nikkiso-vietnam-co-ltd/

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