Company
Changchun Wancheng Bio-Electron Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (11 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 |
| DFQ | Sperm, Antigen, Antiserum, Control | 1 |
| GPN | Antiserum, Typhus Fever | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 |
| LJX | Test, Urine Leukocyte | 1 |
| LNW | Paper, Obstetric Ph | 1 |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | 1 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 1 |
| NRF | Material, Quality Control, Semen Analysis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo Sodium Test;
Vivoo Vitamin C Test;
Vivoo Hydration Test Open, Classified |
JJW | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo Vaginal pH Test Open, Classified |
LNW | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo Protein Test Open, Classified |
JIR | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo pH Test Open, Classified |
CEN | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Exploro Highly Sensitive Male Fertility / Sperm Concentration Test Open, Classified |
DFQ | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Male Fertility Sperm Test for Home Use (Cassette) Open, Classified |
NRF | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. S. Typhi/Para Typhi A Antigen Open, Classified |
GPN | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Menopause Test Cassette (Urine) Open, Classified |
NGA | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. LH One Step Ovulation Test Device (Urine) Open, Classified |
NGE | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips;
URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein;
Vivoo Ketone Tes Open, Classified |
JIN | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. LotFancy Urinary Tract Infection Urine (UTI) Test Strips;
PALINOIA UTI-10 PARAMETER REAGENT STRIPS;
Vaunn Medical 8-in-1 Urinalysis Reagent Strip;
JNW Direct 4-in-1 UTl Urinalysis Test Strips;
Urinify Open, Classified |
LJX | None listed |