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by Biocytech Corporation Sdn Bhd EUDAMED

Active European Union

Ref CB2-10100Model CB1-10100，CB2-10100，CB3-10100，CB4-10100，CB5-10100，CBC-10100，CBS-10100

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number955102041CellsamplingNK Basic UDI-DIDate12 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Disposable Cell Sampling Device
Model / Reference
CB1-10100，CB2-10100，CB3-10100，CB4-10100，CB5-10100，CBC-10100，CBS-10100, CB2-10100
Primary DI / UDI-DI
09551020410160
Basic UDI-DI
955102041CellsamplingNK
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
MY-MF-000047354
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Biocytech Corporation Sdn. Bhd.

See all devices from Biocytech Corporation Sdn. Bhd. →

Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No