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cence

by Hunan Xiang Yi Laboratory Instrument Development Co., Ltd. EUDAMED

Active European Union

Ref H2050RModel TDZ4-WS,TD4,LT53,TD3,L550,TDZ5-WS,L420-A,L500-A,L600-A,XKA-2200, TG12M,TXD3,TDZ4K,CH12R,CH16R,CHT210,HT190,H1850,H1650,TG16-WS, H1750R,HT165R,CL8R,CL5R,CL5 ,DL-6M,HT190R,L530R,HT200,H1750,HT165,H1650K,TGL-16, H1650-W,M16,TD-24K, PRP400,PRP500,L720R-3,etc.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697140297XYCEN0205WE Basic UDI-DIDate10 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
Centrifuge
Model / Reference
TDZ4-WS, TD4, LT53, TD3, L550, TDZ5-WS, L420-A, L500-A, L600-A, XKA-2200, TG12M, TXD3, TDZ4K, CH12R, CH16R, CHT210, HT190, H1850, H1650, TG16-WS, H1750R, HT165R, CL8R, CL5R, CL5, DL-6M, HT190R, L530R, HT200, H1750, HT165, H1650K, TGL-16, H1650-W, M16, TD-24K, PRP400, PRP500, L720R-3, etc., H2050R
Primary DI / UDI-DI
06971402970250
Basic UDI-DI
697140297XYCEN0205WE
EMDN Code
W02069003 Centrifuges
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000036982
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: General-purpose centrifuge IVD

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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