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orthogold100

by MTS Medical AG (Aktiengesellschaft) Germany EUDAMED

Ref 1000008, 1000001Model OW100/OW100S

EMDN Z12139001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426048457OW100OW100SZB Basic UDI-DIDate28 Jan 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
OW100/OW100S, 1000008, 1000001
Primary DI / UDI-DI
04260484571328, 04260484571304
Basic UDI-DI
426048457OW100OW100SZB
Direct Marketing DI
04260484571328
04260484571304
EMDN Code
Z12139001 Shock wave therapy equipment
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005447

Other devices from MTS Medical AG (Aktiengesellschaft)

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 (2)

  • EUDAMED 693ce887-b629-4748-8cc9-6819c00dfd33 61 fields · synced 24 Oct 2026
  • EUDAMED 04260484571304|426048457OW100OW100SZB 61 fields · synced 19 May 2026