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Upper limb intelligent rehabilitation robot
EUDAMEDClass I (EU MDR)
Ref ZEPU-AI2Model ZEPU-AI2，ZEPU-AI4Ref ZEPU-AI4
Identity
- Device Name
- Upper limb intelligent rehabilitation robot EUDAMED
- Model / Reference
- ZEPU-AI2，ZEPU-AI4 EUDAMEDZEPU-AI2 EUDAMEDZEPU-AI4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976632570010 EUDAMED06976632570027 EUDAMED
- Basic UDI-DI
- 697663257ULIRR001QP 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
Upper limb intelligent rehabilitation robot by Shandong Zepu Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697663257ULIRR001QP | 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 (2)
- EUDAMED f37dc25e-e12b-404e-9de2-76492bda99e4 61 fields · synced Sep 18, 2026
- EUDAMED be41732e-3ae0-4cc7-babb-4a9ce841ff0b 61 fields · synced Sep 18, 2026