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Hubang HBLD3-B

by Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd

Ref HBLD3-BModel HBD3A-UL001 HBD3A-UL002 HBD3A-TK002 HBD3B-UL001 HBD3B-UL002 HBD3E-HP001 HBCF- A001 HBCF- B001 HBCF- B002

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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06944387010150 UDI-DI Date23 Jul 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69443870HBELE001S82 Basic UDI-DI 06944387010150UDI-DIDate24 Oct 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
Hubang
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Device Name
Electric Wheelchair
Model / Reference
HBLD3-B, HBD3A-UL001 HBD3A-UL002 HBD3A-TK002 HBD3B-UL001 HBD3B-UL002 HBD3E-HP001 HBCF- A001 HBCF- B001 HBCF- B002
Primary DI / UDI-DI
06944387010150
Basic UDI-DI
69443870HBELE001S82
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 market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

Related devices

Category: Electric-motor-driven wheelchair, occupant-controlled

Cleared under the same submission (K240913)

Other devices from Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd

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Properties

  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No