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Automated Immunoblotting Analyzer IB60 Plus-A

by Zhongshan Ruifu Medical Equipment Technology Co., Ltd

Ref 900-IB60PA-010Model IB60 Plus-A

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 Number6949841906IB002C9 Basic UDI-DI 06949841906024UDI-DIDate27 Aug 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  • Withdrawn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

Model / Reference
IB60 Plus-A, 900-IB60PA-010
Primary DI / UDI-DI
06949841906024
Basic UDI-DI
6949841906IB002C9
Direct Marketing DI
06949841906024
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000057702
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Zhongshan Ruifu Medical Equipment 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