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Rogue DT

by Ki Mobility LLC

Ref Rogue DTModel Manual Wheelchair

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850013379MANUALWN Basic UDI-DI 00840363375540UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840363375540 UDI-DI Date11 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Rogue DT EUDAMED
Ki GUDID
Generic Name
Push-rim manual wheelchair, non-bariatric
Model / Ref / Catalog
Manual Wheelchair, Rogue DT, RogueDT
Primary DI / UDI-DI
00840363375540
Basic UDI-DI
0850013379MANUALWN
510(k) Number
FDA Product Code
IOR
EMDN Code
Y122106 Rear self-propelled wheelchairs
GMDN Term
Push-rim manual wheelchair, non-bariatric
Device Class
Class I
Regulation Number
890.3850
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000012633
Authorised representative
Etac Supply Center AB SE-AR-000001601

Other devices from Ki Mobility, LLC

See all devices from Ki Mobility, LLC →

Properties

  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No