Facility

CHANGCHUN WANCHENG BIO-ELECTRON 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)	3008987086
Establishment type	Manufacture Medical Device
Location	No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin Changchun Jilin, CN 13000
Registration status	Active · expires 2026
Parent company	Changchun Wancheng Bio-Electron Co., Ltd. (owner-operator 10049606)
Brand names	Gastric Aspirate ph test; JNW PH Test Strips - 0-14 PH 200 Pack; pH 0-14; pH Paper Test Strips Kit for Results in Seconds with Litmus Paper, pH Scale 4.5-9; URS 3N teststrip; pH Testing Strips 120ct; Universal Ph Test Strip (4.5 - 9); JNW pH Test Strips 0-14; Urinary Test Non-Quant., PH; dye-indicator, ph (urinary,non-quantitative); JNW PH Test Strips - 4.5-9 PH 200 Pack; JNW pH Test Strips 4.5-9; Body pH Levels Test Strips to Track and Monitor Your pH Balance Test Strips for Women

Activity by year

Recalls (1)

Devices registered here (1)

Dye-Indicator, Ph (Urinary, Non-Quantitative)
Product code CEN (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1550

Recalls & enforcement

Class IIOngoing2025-11-22
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

All facilities operated by Changchun Wancheng Bio-Electron 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. “CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. (FEI 3008987086) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008987086-changchun-wancheng-bio-electron-co-ltd/

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