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Extracorporeal Shockwave Therapy (ESWT)

by İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi Türkiye EUDAMEDGUDID

Ref IMED-850Model Modus ED Product code ISAEMDN Z12139001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08680050920361 Basic UDI-DIDate31 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08680050920361 UDI-DIDate20 Mar 2024ListedStatusListed

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Extracorporeal Shockwave Therapy (ESWT) EUDAMED
Inceler Medikal GUDID
Generic Name
Pneumatic orthopaedic extracorporeal shock wave therapy system
Device Name
Extracorporeal Shockwave Therapy
Model / Ref / Catalog
Modus ED, IMED-850, Modus F
Primary DI / UDI-DI
08680050920361 EUDAMED
08680050920019 GUDID
Basic UDI-DI
B-08680050920361
FDA Product Code
ISA
EMDN Code
Z12139001 Shock wave therapy equipment
GMDN Term
Pneumatic orthopaedic extracorporeal shock wave therapy system
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
890.5660
Market of Registration
Italy
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Modus ED
IMED-850
GUDID
Modus F
Primary DI / UDI-DIEUDAMED
08680050920361
GUDID
08680050920019
Device ClassEUDAMED
Class IIb
GUDID
Class I

Manufacturer details

EUDAMED SRN
TR-MF-000024864

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Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 373a28e4-a68e-4f17-9232-120811ee3fff 61 fields · synced 22 Oct 2026
  • FDA UDI c24fae6b-916b-48b1-b77d-f047c17e8e9a 36 fields · synced 30 May 2026