SAFElife™ WDTH-114-10BX
by Wondfo USA Co., Ltd. GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810174470864 | Date5 Dec 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- SAFElife™
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Reference
- WDTH-114-10BX
- Primary DI / UDI-DI
- 00810174470864
- 510(k) Number
- FDA Product Code
- NFW
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device Class
- Class II
- Regulation Number
- 862.3870
- Commercial Distribution
- In Commercial Distribution
Other devices from Wondfo USA Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No