Facility

IntroMedic 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)	3013684328
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	F-RTEK 4F, 11-25, Simin-daero 327 beon-gil Anyang-si Gyeonggi, KR 14055
Registration status	Active · expires 2026
Parent company	IntroMedic Co., Ltd. (owner-operator 10027343)
Brand names	MiroCam Receiver: MR2000; MiroCam Software: MiroView U 4; MiroCam Capsule: MC2000-B; Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L); MiroCam Capsule Endoscope System

Activity by year

Recalls (1)

Devices registered here (1)

System, Imaging, Gastrointestinal, Wireless, Capsule
Product code NEZ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1300

Recalls & enforcement

Class IITerminated2017-02-15
When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.

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. “IntroMedic Co., Ltd. (FEI 3013684328) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013684328-intromedic-co-ltd/

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