Facility

INTROMEDIC CO., LTD

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	3007244127
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Suite 1105 1106 E&C Venture Dream Tower 6-Cha Seoul, KR 15271
Registration status	Active · expires 2026
Parent company	IntroMedic Co., Ltd. (owner-operator 10027343)
Brand names	MiroCam Capsule: MC1600-B; MiroCam Software: MiroView U 4; MiroCam Capsule Endoscope System; MiroCam Receiver: MR2000; Data Cable / Data Belt: MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)

Activity by year

Recalls (1)
Inspections (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.

FDA inspections (1)

VAI2017-07-04
Voluntary 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.

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 3007244127) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007244127-intromedic-co-ltd/

Not open yet

Alerts for INTROMEDIC CO., LTD

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.