| Primary Device ID | 00810174471052 |
| NIH Device Record Key | a65a3cff-fd38-4c82-8c96-4c6f5afbddae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HORMONElife™ |
| Version Model Number | DWS-H10L20-H |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| Device Count | 30 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810174471052 [Unit of Use] |
| GS1 | 10810174471059 [Primary] |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2025-12-05 |
| 10816862027263 | HORMONElife™ PdG Urine Test Strip OTC 6PK |
| 10816862027249 | HORMONElife™ Ultra Accurate FSH Test Strip OTC 6PK |
| 00816862027754 | HORMONElife™ Pregnancy Home Test Midstream |
| 00816862027747 | HORMONElife™ Early Result Pregnancy Test Midstream |
| 00810174471113 | HORMONELife 50+100 Strip Combo; 50 hCG Pregnancy Test + 100 LH Ovulation |
| 00810174471090 | HORMONELife 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation |
| 00810174471076 | HORMONELife 15+40 Strip Combo; 15 hCG Pregnancy Test + 40 LH Ovulation |
| 00810174471052 | HORMONELife 10+20 Strip Combo; 10 hCG Pregnancy Test + 20 LH Ovulation |