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Active and Passive Trainer for Upper and Lower Limbs
EUDAMEDClass I (EU MDR)
Ref N/AModel HNT-LE-HF001、HNT-LE-HF002、HNT-LE-HF003、HNT-LE-HF021、HNT-LE-HF022、HNT-LE-HF023
Identity
- Device Name
- Active and Passive Trainer for Upper and Lower Limbs EUDAMED
- Model / Reference
- HNT-LE-HF001、HNT-LE-HF002、HNT-LE-HF003、HNT-LE-HF021、HNT-LE-HF022、HNT-LE-HF023 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976394920016 EUDAMED
- Basic UDI-DI
- 697639492AAPTFUALL79 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
Active and Passive Trainer for Upper and Lower Limbs by Humaneotec Medical Equipment (Hunan) 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 | 697639492AAPTFUALL79 | 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 6ff7858a-4d5a-4443-b31f-89256c959b13 61 fields · synced Jul 10, 2026