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Massage Ball

by Zhenjiang R&X Technology Co., Ltd. China EUDAMED

Ref RX-1216/BModel RX-1202 EMDN Z12069099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697816810Mball54 Basic UDI-DIDate19 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Massage Ball
Model / Reference
RX-1202, RX-1216/B
Primary DI / UDI-DI
06978168100167
Basic UDI-DI
697816810Mball54
EMDN Code
Z12069099 Various physiotherapy and rehabilitation instruments - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000046841
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhenjiang R&X Technology Co., Ltd.

See all devices from Zhenjiang R&X Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 4845d5ac-2d89-4134-8e2c-66593e73c6e5 61 fields · synced 23 Oct 2026