Skip to content

EN-Dynamic Rotator 1455966

by Enraf-Nonius B.V.

Part of a family of 16 devices: see the family page

Ref 1455966

EN-Dynamic Rotator 1455966 is a core-body mechanical weight exerciser (EU MDR Class I; FDA Class I; FDA product code BXB, Exerciser, Powered) made by Enraf-Nonius B.V., registered in EUDAMED on 20 May 2026 (Basic UDI-DI 871999250814559004Y) and listed in FDA GUDID since 11 Feb 2025 (UDI-DI 08719992508327), 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 Number871999250814559004Y Basic UDI-DI 08719992508327UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719992508327 UDI-DI Date11 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 871999250814559004Y registered 20 May 2026 Active
  • FDA GUDID UDI-DI 08719992508327 listed 11 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719992508327
  2. Registered EUDAMED 871999250814559004Y

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  • Withdrawn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
EN-Dynamic Rotator
Generic name
Core-body mechanical weight exerciser
Device name
EN-Dynamic
Model / reference
1455966
Primary DI / UDI-DI
08719992508327
Basic UDI-DI
871999250814559004Y
Direct marketing DI
08719992508327
FDA product code
BXB
EMDN code
Z120602 Physiotherapy equipment
GMDN term
Core-body mechanical weight exerciser
Device class
Class I
Regulation number
890.5380
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Core-body mechanical weight exerciser

Similar devices in this category

Other devices filed under PHYSIOTHERAPY EQUIPMENT.

Other devices from Enraf-Nonius B.V.

See all devices from Enraf-Nonius B.V. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)