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Mckd-05

by Zenith Lab (Jiangsu) Co., Ltd

Ref MCKD-05

Mckd-05 is an in vitro diagnostic device (EU IVDR Class A; EMDN category centrifuges) made by Zenith Lab (Jiangsu) Co., Ltd, registered in EUDAMED on 30 Jul 2024 (Basic UDI-DI 697637433MCKD-05SN), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697637433MCKD-05SN Basic UDI-DI 06976374330620UDI-DIDate30 Jul 2024RegisteredStatusActive

Official records

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  • Withdrawn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
Mckd-05
Model / reference
MCKD-05
Primary DI / UDI-DI
06976374330620
Basic UDI-DI
697637433MCKD-05SN
EMDN code
W02069003 Centrifuges
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000026595
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

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Other devices filed under CENTRIFUGES.

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Properties

  • IVD instrument
Other properties (12, all answered No)