Facility

TAEWOONG MEDICAL 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)	3003902943
Establishment type	Manufacture Medical Device
Location	14 Gojeong-ro, Wolgot-myeon Gimpo-Si Gyeonggi, KR 10022
Registration status	Active · expires 2026
Parent company	TAEWOONG MEDICAL CO., LTD (owner-operator 9054381)
Brand names	Niti-S Colonic Comfort Stent; Niti-S Duodenal Comfort Stent

Activity by year

Recalls (1)

Devices registered here (2)

Stent, Colonic, Metallic, Expandable
Product code MQR (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3610
Stent, Metallic, Expandable, Duodenal
Product code MUM (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3610

Recalls & enforcement

Class IITerminated2019-10-18
Misprinted IFUs shipped with esophageal stents

All facilities operated by TAEWOONG MEDICAL CO., LTD

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. “TAEWOONG MEDICAL CO., LTD (FEI 3003902943) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003902943-taewoong-medical-co-ltd/

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