Skip to content

cence

by Hunan Xiang Yi Laboratory Instrument Development Co., Ltd. 145 variants

Ref Auto 50RModel 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.

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 Number697140297XYCEN0205WE Basic UDI-DI 06971402971264UDI-DIDate10 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  • Withdrawn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
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., Auto 50R
Primary DI / UDI-DI
06971402971264
Basic UDI-DI
697140297XYCEN0205WE
EMDN Code
W02069003 Centrifuges
Device Class
Class A
EU 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

Other devices from Hunan Xiang Yi Laboratory Instrument Development Co., Ltd.

See all devices from Hunan Xiang Yi Laboratory Instrument Development Co., Ltd. →

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