cence

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

Active European Union

Ref BC 16RModel 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

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697140297XYCEN0205WE Basic UDI-DI	Date10 Aug 2023Registered	StatusActive

Coverage

1 jurisdiction

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Withdrawn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., BC 16R

Primary DI / UDI-DI: 06971402970984
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

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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