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Vocic

by Anhui JBH Medical Apparatus Co., Ltd 2 variants

Model DC01

Vocic (DC01) is a device classified as Class I in the EU and Class II in the US made by Anhui Jbh Medical Apparatus Co., Ltd, registered in EUDAMED on 24 Jul 2024 (Basic UDI-DI 697317553JBHDC01038Q), cleared under FDA 510(k) K212092 on 6 May 2022 and listed in FDA GUDID since 5 Jul 2024 (UDI-DI 06973175530457), 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) K212092

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 Number697317553JBHDC01038Q Basic UDI-DI 06973175530457UDI-DIDate24 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06973175530457 UDI-DI Date5 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212092 Date6 May 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697317553JBHDC01038Q registered 24 Jul 2024 Active
  • FDA 510(k) K212092 decided 6 May 2022 Active
  • FDA GUDID UDI-DI 06973175530457 listed 5 Jul 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212092
  2. Listed FDA GUDID 06973175530457
  3. Registered EUDAMED 697317553JBHDC01038Q

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  • Withdrawn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

Generic name
Electric-motor-driven wheelchair, occupant-controlled
Device name
Electric Wheelchair
Model / reference
DC01
Primary DI / UDI-DI
06973175530457
Basic UDI-DI
697317553JBHDC01038Q
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

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)