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Ultrasonic Pocket Doppler
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SD2Ref SONOTRAX LiteRef SD2 PlusRef SONOTRAX II ProRef SD3Ref SONOTRAX Basic ARef SONOTRAX ProRef SD3 PLUSRef SD2 Lite
Identity
- Trade Name
- Ultrasonic Pocket Doppler EUDAMEDFDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- Ultrasonic Pocket Doppler EUDAMED
- Model / Reference
- SD2 EUDAMEDSONOTRAX Lite EUDAMEDFDA UDISD3 PLUS EUDAMEDFDA UDISD3 EUDAMEDFDA UDISONOTRAX Basic A EUDAMEDFDA UDISONOTRAX Pro EUDAMEDFDA UDISD2 Plus EUDAMEDSONOTRAX II Pro EUDAMEDSD2 Lite EUDAMEDSONOTRAX Ⅱ Pro FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413817241 EUDAMED06944413800120 EUDAMEDFDA UDI06944413801806 EUDAMEDFDA UDI06944413800175 EUDAMEDFDA UDI06944413801783 EUDAMEDFDA UDI06944413800144 EUDAMEDFDA UDI06944413800151 EUDAMEDFDA UDI06944413817265 EUDAMED06944413817289 EUDAMED
- Basic UDI-DI
- 69444138SD2SU4 EUDAMED69444138SonotraxSC8 EUDAMED69444138SD3SU7 EUDAMED
- 510(k) Number
- K140579 FDA UDI
- FDA Product Code
- KNG FDA UDIDPW FDA UDIHEP 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 UDI870.2100 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
MR Unsafe FDA UDI
Ultrasonic Pocket Doppler by Edan Instruments, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444138SD2SU4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (15)
- EUDAMED e03ba3df-ebf9-4fc3-8737-b2e3cbf2e986 61 fields · synced Aug 3, 2026
- EUDAMED ac053ba0-cdf1-4249-af38-b359bdbfe413 61 fields · synced May 17, 2026
- FDA UDI fef14be3-ebd0-4576-b328-bbfe42cb3e5a 33 fields · synced May 29, 2026
- FDA UDI a5d91410-1190-4a92-9e92-a4ee3fa56efd 32 fields · synced May 30, 2026
- FDA UDI dfc7b56d-d72f-44e0-93f6-519e060171c4 33 fields · synced May 30, 2026
- FDA UDI ec6cfacf-d63f-4e30-834a-0608298a5548 32 fields · synced May 30, 2026
- FDA UDI 430fe899-799d-4798-b1d8-a1727c007660 32 fields · synced May 30, 2026
- FDA UDI aaf8c8c0-bfe0-491a-b1a9-4cd5d64f3fba 32 fields · synced May 30, 2026
- EUDAMED ea5daa32-d9ea-4060-8997-f68dcbb72e30 61 fields · synced Jul 10, 2026
- EUDAMED 6c46a8a3-8f48-410a-aa8b-84bc5af11724 61 fields · synced Jul 10, 2026
- EUDAMED 935eee62-d39e-4adc-8f4e-aaca81810b52 61 fields · synced Jul 13, 2026
- EUDAMED f89f7943-665e-40ce-ae74-2a046393ff6b 61 fields · synced Jul 16, 2026
- EUDAMED bcd7dba0-7d6c-4eec-a959-0f7f7e0ad907 61 fields · synced Jul 16, 2026
- EUDAMED a7ff35d0-2b05-4120-a310-e7436ba7373e 61 fields · synced Jul 29, 2026
- EUDAMED 6e00931c-3613-4d72-b195-af09e58444f3 61 fields · synced Jul 30, 2026