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Hand of Hope

by Rehab-Robotics Company Limited 14 variants

Ref HOH5-PSM-R-W

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489711322HOH5H5 Basic UDI-DI 04897113220137UDI-DIDate19 Mar 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number04897113220137 UDI-DI Date24 Nov 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Virtual-display rehabilitation system, powered-support, upper-limb
Model / Reference
HOH5-PSM-R-W
Primary DI / UDI-DI
04897113220137
Basic UDI-DI
489711322HOH5H5
FDA Product Code
BXB
EMDN Code
Z120616 Electromechanical systems for physical therapy
GMDN Term
Virtual-display rehabilitation system, powered-support, upper-limb
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
890.5380
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
HK-MF-000040022
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Rehab-Robotics Company Limited

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No