Identity
- Trade Name
- Ultrasonic Pocket Doppler FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- Ultrasonic Pocket Doppler EUDAMED
- Model / Reference
- SD1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413808768 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138SD12Z EUDAMED
- 510(k) Number
- K172780 FDA UDI
- FDA Product Code
- KNG FDA UDI
- EMDN Code
- Z12080103 FOETAL HEARTBEAT DETECTORS 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
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 | K172780 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K140579 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138SD12Z | 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 b6a72cd6-dba0-416c-92b0-ab607a7ddaee 61 fields · synced Aug 4, 2026
- FDA UDI 6e563eb1-4666-4136-8628-8e64636a591e 33 fields · synced May 30, 2026
- FDA 510(k) K172780 1 fields · synced May 18, 2026