Identity
- Trade Name
- Fetal Doppler EUDAMED
- Device Name
- Fetal Doppler EUDAMED
- Model / Reference
- JPD-100S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951740501026 EUDAMED
- Basic UDI-DI
- 69517405SH01SC EUDAMED
- Direct Marketing DI
- 06951740501026 EUDAMED
- EMDN Code
- Z12080103 FOETAL HEARTBEAT DETECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Fetal Doppler by Shenzhen Jumper Medical Equipment Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, 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 | K110124 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69517405SH01SC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000014343
- FDA Applicant
- Shenzhen Jumper Medical Equipment Co., Ltd.
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 194df02e-cda0-48d9-a143-f999b41960e5 85 fields · synced Jun 18, 2026
- FDA 510(k) K110124 1 fields · synced May 18, 2026