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Active and Passive Trainer for Upper and Lower Limbs（Portable）
EUDAMEDClass I (EU MDR)
Ref N/AModel HNT- LE - HF011、HNT- LE - HF012、HNT- LE - HF013、HNT- LE - HF014、HNT- LE - HF015、HNT- LE - HF016
Identity
- Device Name
- Active and Passive Trainer for Upper and Lower Limbs（Portable） EUDAMED
- Model / Reference
- HNT- LE - HF011、HNT- LE - HF012、HNT- LE - HF013、HNT- LE - HF014、HNT- LE - HF015、HNT- LE - HF016 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976394920085 EUDAMED
- Basic UDI-DI
- 697639492AAPTFUALLPYJ 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
Active and Passive Trainer for Upper and Lower Limbs（Portable） by Humaneotec Medical Equipment (Hunan) Co., Ltd — Class I — MDR — listed in EUDAMED
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 | 697639492AAPTFUALLPYJ | Class I | Active |
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Manufacturer
- Manufacturer
- Humaneotec Medical Equipment (Hunan) Co., Ltd
- EUDAMED SRN
- CN-MF-000035365
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED fdadb0d8-3c2e-4317-8f7a-e1b80854e3f9 61 fields · synced May 22, 2026