Identity
- Trade Name
- Fetal Doppler EUDAMEDFDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- Fetal Doppler EUDAMED
- Model / Reference
- JPD-100S4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06951740501040 EUDAMED06951740500029 FDA UDI
- Basic UDI-DI
- 69517405SH01SC EUDAMED
- Direct Marketing DI
- 06951740501040 EUDAMED
- 510(k) Number
- K110124 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fetal Doppler by Shenzhen Jumper Medical Equipment Co., Ltd — 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 | 69517405SH01SC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000014343
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 1d02daa6-5a8a-4dc1-a795-733dd17e107d 61 fields · synced Oct 5, 2026
- FDA UDI 98e10572-8153-409d-a029-ca02d4cd3a5d 33 fields · synced May 30, 2026