Identity
- Trade Name
- Fetal doppler EUDAMED
- Device Name
- Fetal Doppler EUDAMED
- Model / Reference
- AD50A EUDAMEDAD50D11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394500975 EUDAMED
- Basic UDI-DI
- 69273945FD01SD EUDAMED
- Direct Marketing DI
- 06927394500975 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fetal doppler by Hunan Accurate Bio-Medical Technology Co., Ltd. — Class IIa — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69273945FD01SD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b19403d9-e50c-4980-ab63-a82db3d29c41 61 fields · synced Oct 7, 2026