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Dynamic and Static Balance Evaluation and Training System
EUDAMEDClass I (EU MDR)
Ref ZEPU-AI10plusModel ZEPU-AI10 ZEPU-AI10plus
Identity
- Device Name
- Dynamic and Static Balance Evaluation and Training System EUDAMED
- Model / Reference
- ZEPU-AI10 ZEPU-AI10plus EUDAMEDZEPU-AI10plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976632570423 EUDAMED
- Basic UDI-DI
- 697663257DASBEATSCB EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Rubber dam, Hevea-latex
Dynamic and Static Balance Evaluation and Training System by Shandong Zepu Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED
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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 | 697663257DASBEATSCB | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Zepu Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000037255
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e74c089e-caa3-4e57-bad0-9dbd4a8b8c0d 61 fields · synced Jun 19, 2026