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Int’l THERABAND® Pro Series SCP™ Exercise Ball - 45 cm Yellow (display packaging)

by The Hygenic Company, LLC

Ref 12039Model EXERCISE NON- MEASURING

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00874530000000000000006XT Basic UDI-DI 00087453120394UDI-DIDate12 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Exercise Ball
Model / Reference
EXERCISE NON- MEASURING, 12039
Primary DI / UDI-DI
00087453120394
Basic UDI-DI
00874530000000000000006XT
EMDN Code
Z120603 Passive rehabilitative gymnastics equipment
Device Class
Class I
EU 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