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DST8000 Triple

by DPE Medical EUDAMEDGUDID

Active European Union and United States

Ref DSTT, DSTTXModel DST

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberG535DSTT0 UDI-DIDate20 Jan 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number++G535DSTMODELSRC Basic UDI-DIDate7 Dec 2025RegisteredStatusActive

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/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
DST8000 Triple EUDAMED
DST8000 EUDAMED
DST8000 Triple XL EUDAMED
Dst GUDID
Generic Name
Parallel bar exerciser, powered
Stair-climbing exerciser, non-powered
Model / Ref / Catalog
DST EUDAMED
DSTT EUDAMED
DSTTX EUDAMED
DST8000 Triple GUDID
DST8000 Triple XL GUDID
DST8000 GUDID
Primary DI / UDI-DI
G535DSTT0, G535DST0, G535DSTTX0
Basic UDI-DI
++G535DSTMODELSRC
FDA Product Code
IRR
EMDN Code
Z120602 Physiotherapy equipment
GMDN Term
Parallel bar exerciser, powered
Stair-climbing exerciser, non-powered
Device Class
Class I
Regulation Number
890.5380
Market of Registration
Denmark
Italy
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DST
DSTT
DSTTX
GUDID
DST8000 Triple
DST8000 Triple XL
DST8000

Manufacturer details

EUDAMED SRN
IL-MF-000042640
Authorised representative
Obelis s.a. BE-AR-000000106

From the manufacturer

Manufacturer's product page: DST8000 Triple Pro

Other devices from DPE Medical

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No