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PathTezt Centrifuge Tube

by Biocytech Corporation Sdn Bhd

Ref CT-500Model 1. DT-2100 2. TIPS-48096 3. TIPS-200 4. SP-500 5. CT-500 6. DSC-500

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number955102041CentrifugeKP Basic UDI-DI 09551020410061UDI-DIDate29 May 2026RegisteredStatusActive

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  • Withdrawn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
Centrifuge Consumable
Model / Reference
1. DT-2100 2. TIPS-48096 3. TIPS-200 4. SP-500 5. CT-500 6. DSC-500, CT-500
Primary DI / UDI-DI
09551020410061
Basic UDI-DI
955102041CentrifugeKP
EMDN Code
W02069085 Various sample processing instruments - consumables
Device Class
Class A
EU market of registration
Germany

Manufacturer details

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

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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