Facility

DIGIMED CO., LTD

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

Key facts

1recalls · worst Class II

—inspections in our data

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007933232
Establishment type	Manufacture Medical Device
Location	401, 402, 406~411-ho, A-dong Seoul, KR 08505
Registration status	Active · expires 2026
Parent company	DIGIMED (owner-operator 10034335)
Brand names	HYBRID S70

Activity by year

Recalls (1)
Warning letters (1)

Devices registered here (1)

Unit, X-Ray, Extraoral With Timer
Product code EHD (opens in a new tab) · Class II · Dental · 21 CFR 872.1800

Recalls & enforcement

Class IIOngoing2025-06-19
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

FDA warning letters (1)

Warning Letter2017-03-10
Warning Letter (opens in a new tab) · Seoul

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by DIGIMED

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. “DIGIMED CO., LTD (FEI 3007933232) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007933232-digimed-co-ltd/

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