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MindPod Dolphin DLP-01

by NeuroXtherapeutics SA

Ref DLP-01

MindPod Dolphin DLP-01 is a device classified as Class IIa in the EU and Class II in the US made by NeuroXtherapeutics SA, registered in EUDAMED on 23 Mar 2026 (Basic UDI-DI 376027265DLP0177) and listed in FDA GUDID since 27 Jun 2019 (UDI-DI 03760272650026), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376027265DLP0177 Basic UDI-DI 03760272650026UDI-DIDate23 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760272650026 UDI-DI Date27 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376027265DLP0177 registered 23 Mar 2026 Active
  • FDA GUDID UDI-DI 03760272650026 listed 27 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760272650026
  2. Registered EUDAMED 376027265DLP0177

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
MindPod Dolphin
Generic name
Virtual-display rehabilitation system, non-supportive, clinical
Model / reference
DLP-01
Primary DI / UDI-DI
03760272650026
Basic UDI-DI
376027265DLP0177
FDA product code
QKC
EMDN code
Z12069092 Various physiotherapy and rehabilitation instruments - medical device software
GMDN term
Virtual-display rehabilitation system, non-supportive, clinical
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.5360
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from NeuroXtherapeutics SA

See all devices from NeuroXtherapeutics SA →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)