Identity
- Device Name
- Fetal heart monitor belt EUDAMED
- Model / Reference
- Ref EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972841172731 EUDAMED06972841173189 EUDAMED
- Basic UDI-DI
- 697284117FHMB1157VF EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMEDT0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 heart monitor belt by Zhejiang Mediunion Healthcare Group Co., Ltd. — Class I — 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 | 697284117FHMB1157VF | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Mediunion Healthcare Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000026766
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 001cfae9-3673-4934-a570-8c44c1e9218c 61 fields · synced Oct 6, 2026
- EUDAMED 635ba6fa-7775-4d35-8896-1e877cc706b2 61 fields · synced May 19, 2026