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Active and Passive Trainer for Upper and Lower Limbs(Bedside)

EUDAMED

Class I (EU MDR)

Ref N/AModel HNT-LE-HF031、HNT-LE-HF032、HNT-LE-HF041、HNT-LE-HF042

by Humaneotec Medical Equipment (Hunan) Co., Ltd

Identity

Device Name
Active and Passive Trainer for Upper and Lower Limbs(Bedside) EUDAMED
Model / Reference
HNT-LE-HF031、HNT-LE-HF032、HNT-LE-HF041、HNT-LE-HF042 EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06976394920092 EUDAMED
Basic UDI-DI
697639492AAPTFUALLBXN 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(Bedside) by Humaneotec Medical Equipment (Hunan) Co., Ltd — Class I — MDR — listed in EUDAMED

Similar devices

Also classified as Rubber dam, Hevea-latex.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000035365
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (1)

  • EUDAMED 6796dbe4-a50b-4e9e-9ed1-788a33a45c35 61 fields · synced Jul 27, 2026