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Flow Cytometer

by Shenzhen Wellgrow Biotech Co., Ltd.

Ref EZ03 204P1Model EZ03 204P1,EZ03 206P1,EZ03 208P1,EZ03 308P1,EZ03 310P1,EZ03 313P1,EZ03 314P1

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697282550EZ03LD Basic UDI-DI 06972825505388UDI-DIDate3 Jan 2025RegisteredStatusActive

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  • Withdrawn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
Flow Cytometer
Model / Reference
EZ03 204P1, EZ03 206P1, EZ03 208P1, EZ03 308P1, EZ03 310P1, EZ03 313P1, EZ03 314P1
Primary DI / UDI-DI
06972825505388
Basic UDI-DI
697282550EZ03LD
EMDN Code
W02020499 Flow cytometry instruments - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000022880
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Wellgrow Biotech Co., Ltd.

See all devices from Shenzhen Wellgrow Biotech 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