Facility

EXACT MEDICAL MANUFACTURING, INC.

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)	3018781093
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	No. 101 Huashan Road Changzhou Jiangsu, CN 21303
Registration status	Active · expires 2026
Parent company	Exact Medical Manufacturing, Inc. (owner-operator 10053949)
Brand names	EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES

Activity by year

Recalls (1)

Devices registered here (1)

Drape, Surgical, Antimicrobial
Product code KKX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370

Recalls & enforcement

Class IITerminated2021-04-29
No 510k for the product to be used in a natural or surgical opening to the body

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. “EXACT MEDICAL MANUFACTURING, INC. (FEI 3018781093) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3018781093-exact-medical-manufacturing-inc/

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