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Devita

by Anhui JBH Medical Apparatus Co., Ltd

Ref DC10L

Devita (DC10L) is an electric-motor-driven wheelchair (EU MDR Class I; FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Anhui Jbh Medical Apparatus Co., Ltd, registered in EUDAMED on 29 Apr 2025 (Basic UDI-DI 697317553JBHDC10L04S5), cleared under FDA 510(k) K242252 on 27 Dec 2024 and listed in FDA GUDID since 1 Apr 2025 (UDI-DI 06973175530587), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242252

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697317553JBHDC10L04S5 Basic UDI-DI Date29 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06973175530587 UDI-DI Date1 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242252 Date27 Dec 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697317553JBHDC10L04S5 registered 29 Apr 2025 Active
  • FDA 510(k) K242252 decided 27 Dec 2024 Active
  • FDA GUDID UDI-DI 06973175530587 listed 1 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242252
  2. Listed FDA GUDID 06973175530587
  3. Registered EUDAMED 697317553JBHDC10L04S5

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Devita EUDAMED
Jbh EUDAMEDGUDID
Generic name
Electric-motor-driven wheelchair, occupant-controlled
Device name
Electric wheelchair
Model / reference
DC10L
Primary DI / UDI-DI
06973175530587, 06973175530426
Basic UDI-DI
697317553JBHDC10L04S5, 697317553JBHDC10L02RZ
510(k) Number
FDA product code
ITI
EMDN code
Y122127 Electric wheelchairs
GMDN term
Electric-motor-driven wheelchair, occupant-controlled
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.3860
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 I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CN-MF-000008809
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Similar devices in this category

Other devices filed under ELECTRIC WHEELCHAIRS.

Other devices from Anhui Jbh Medical Apparatus Co., Ltd

See all devices from Anhui Jbh Medical Apparatus Co., Ltd →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)