Identity
- Trade Name
- Fetal Doppler EUDAMEDJUMPER FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Fetal Doppler EUDAMED
- Model / Reference
- JPD-100B4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06951740520294 EUDAMEDFDA UDI
- Basic UDI-DI
- 69517405SH01SC EUDAMED
- Direct Marketing DI
- 06951740520294 EUDAMED
- 510(k) Number
- K140582 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z12080103 FOETAL HEARTBEAT DETECTORS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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 d33a7c66-e664-4e75-b3b5-6a6dd9da5635 61 fields · synced Jun 9, 2026
- FDA UDI bc660a79-4cc5-45c1-bd0c-017f97898106 33 fields · synced May 30, 2026