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Superight

by Zhejiang Zhonglei Medical Technology Co.Ltd

Ref N6101Model N6101、N6101A、N6102、N6103、N6103A、N6105、N6105A、N6106、N6106A、N6107、N6108、N6109、N6201、N6201A、N6201B、W6202、W6202A、W6202B、W6203、W6203A、W6203B、W6205

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977100780009 UDI-DI Date11 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697710078PW01ME Basic UDI-DI 06977100780009UDI-DIDate9 Jan 2024RegisteredStatusActive

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 24 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  • Withdrawn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
Superight EUDAMED
Zhonglei GUDID
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Device Name
Power Wheelchair
Model / Reference
N6101、N6101A、N6102、N6103、N6103A、N6105、N6105A、N6106、N6106A、N6107、N6108、N6109、N6201、N6201A、N6201B、W6202、W6202A、W6202B、W6203、W6203A、W6203B、W6205 EUDAMED
N6101 EUDAMED
Power wheelchair(N6101) GUDID
Primary DI / UDI-DI
06977100780009
Basic UDI-DI
697710078PW01ME
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
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000039322
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhejiang Zhonglei Medical Technology Co.Ltd

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No