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Disposable diseased cell collectors

by Lind Membrane（Xiamen） Healthcare Co., Ltd.

Ref LIND-CC-01 01Model LIND-CC-01 01/02/03/04/05/06/07/08/09 /10/11/12/13/14/15/16 K002 01/02/03/04/05/06/07/08/09 /10/11/12/13/14/15/16

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697652108DDCC01DC Basic UDI-DI 06976521080071UDI-DIDate28 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Disposable diseased cell collectors
Model / Reference
LIND-CC-01 01/02/03/04/05/06/07/08/09 /10/11/12/13/14/15/16 K002 01/02/03/04/05/06/07/08/09 /10/11/12/13/14/15/16, LIND-CC-01 01
Primary DI / UDI-DI
06976521080071
Basic UDI-DI
697652108DDCC01DC
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000035642
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Lind Membrane（Xiamen） Healthcare Co., Ltd.

Properties

  • Self Testing
  • Near-Patient Testing
  • Companion Diagnostics

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Surgical Instrument: No
  • New Device: No