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Ultrasonic Pocket Doppler
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SONOTRAX Vascular510(k) K040480
Identity
- Trade Name
- Ultrasonic Pocket Doppler FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- Ultrasonic Pocket Doppler EUDAMED
- Model / Reference
- SONOTRAX Vascular EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413800564 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138SonotraxVCE EUDAMED
- FDA Product Code
- KNG FDA UDIHEP FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Foetal Doppler system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ultrasonic Pocket Doppler by Edan Instruments, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040480 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138SonotraxVCE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED a67a253d-1e6a-4ee9-94aa-cc6a684d05b0 85 fields · synced Jun 18, 2026
- FDA UDI 5feee2aa-6667-4e29-9a48-5fd70d3dba99 32 fields · synced May 30, 2026
- FDA 510(k) K040480 1 fields · synced May 18, 2026