Mediblu FD1
Mediblu FD1 (MDB01009) is a foetal Doppler system (FDA Class II; FDA product code HEP, Monitor, blood-flow, ultrasonic) made by Mediblu Medical, LLC, listed in FDA GUDID since 25 Jun 2020 (UDI-DI B632MDB01009), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB632MDB01009 | Date25 Jun 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Mediblu
- Generic name
- Foetal Doppler system
- Model / Ref / Catalog
- FD1, MDB01009
- Primary DI / UDI-DI
- B632MDB01009
- FDA product code
- HEP
- GMDN term
- Foetal Doppler system
- Device class
- Class II
- Regulation number
- 884.2660
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Foetal Doppler system.