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Lymacyte Series Spectruml Flow Cytometers

by Shanghai Nokayun Medical Technology Co., Ltd. 3 variants

Ref Lymacyte(V-B-Y-R-UV)Model Lymacyte(V-B-Y-R)、Lymacyte(V-B-Y)、Lymacyte(B-Y-R)、Lymacyte(V-B-R)、Lymacyte(V-B)、Lymacyte(B-Y)、Lymacyte(B-R)、Lymacyte(B)

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 Number697982486LSFSFC001EC Basic UDI-DI 06979824860098UDI-DIDate13 Mar 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  • Withdrawn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
Lymacyte Series Spectruml Flow Cytometers
Model / Reference
Lymacyte(V-B-Y-R)、Lymacyte(V-B-Y)、Lymacyte(B-Y-R)、Lymacyte(V-B-R)、Lymacyte(V-B)、Lymacyte(B-Y)、Lymacyte(B-R)、Lymacyte(B), Lymacyte(V-B-Y-R-UV)
Primary DI / UDI-DI
06979824860098
Basic UDI-DI
697982486LSFSFC001EC
EMDN Code
W02020499 Flow cytometry instruments - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051537
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Nokayun Medical Technology 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