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Upper and Lower Limbs Active And Passive Rehabillitation Exercise Trainer

by Shandong Zepu Medical Technology Co., Ltd 12 variants

Ref ZEPU-K2000BModel ZEPU-K2000A,ZEPU-K2000B,ZEPU-K2000C,ZEPU-K2000D,ZEPU-K2000E,ZEPU-K2000K,ZEPU-K2000F,ZEPU-K2000G,ZEPU-K2000H,ZEPU-AI7A,ZEPU-AI7B,ZEPU-AI7D

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

The Upper and Lower Limbs Active And Passive Rehabillitation Exercise Trainer is a cutting-edge medical device designed to provide comprehensive rehabilitation exercises for individuals with upper and lower limb injuries or disabilities. This innovative device offers both active and passive rehabilitation features, ensuring effective recovery and improvement in overall mobility.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697663257UALLAAPRETYX Basic UDI-DI 06976632570102UDI-DIDate2 Apr 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
ZEPU-K2000A, ZEPU-K2000B, ZEPU-K2000C, ZEPU-K2000D, ZEPU-K2000E, ZEPU-K2000K, ZEPU-K2000F, ZEPU-K2000G, ZEPU-K2000H, ZEPU-AI7A, ZEPU-AI7B, ZEPU-AI7D
Primary DI / UDI-DI
06976632570102
Basic UDI-DI
697663257UALLAAPRETYX
EMDN Code
Y0504 Arms, torso and legs re-education devices
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000037255
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Rubber dam, Hevea-latex

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No