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Rolyan 2oz Therapy Putty – Extra Firm Grey

by The Hygenic Company, LLC EUDAMED

Active European Union

Ref 081249424Model EXERCISE NON- MEASURING

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00874530000000000000009XZ Basic UDI-DIDate19 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Hand Trainer
Model / Reference
EXERCISE NON- MEASURING, 081249424
Primary DI / UDI-DI
00087453001310
Basic UDI-DI
00874530000000000000009XZ
EMDN Code
Y0503 Hands and fingers re-education devices
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000003317
Authorised representative
AR Experts B.V. NL-AR-000023989

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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