HORMONElife™

GUDID 00816862027754

HORMONElife™ Pregnancy Home Test Midstream

WONDFO USA CO., LTD.

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00816862027754
• NIH Device Record Key: a46c7555-b32f-4a51-8057-1bb39f373797
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HORMONElife™
• Version Model Number: H1-M-25BX
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 25
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862027754 [Unit of Use]
GS1	00816862027761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043443

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-08
• Device Publish Date: 2025-11-28

On-Brand Devices [HORMONElife™]

• 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