NA 3MHz
by Edan Instruments, Inc. 2 variants
Ref SD5-3MHz
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number6944138UTOBC9 06944413805644 | Date10 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06944413805644 | Date1 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Ultrasonic Transducer
- Generic Name
- Foetal Doppler system probe
- Model / Reference
- SD5-3MHz EUDAMED3MHz GUDID
- Primary DI / UDI-DI
- 06944413805644
- Basic UDI-DI
- 6944138UTOBC9
- 510(k) Number
- FDA Product Code
- KNG
- EMDN Code
- Z11040299 Ultrasound probes – other
- GMDN Term
- Foetal Doppler system probe
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 884.2660
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | SD5-3MHz | 3MHz |
| Device Class | Class IIa | Class II |
Other devices from Edan Instruments, Inc.
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No