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Cell culture

by Hangzhou Agen Biotechnology Co Ltd 47 variants

Ref C000100Model C000035，C000060，C000100，C000035W，C000060W，C000100W，C001035，C001060，C001100，C001035W，C001060W，C001100W，C010001，etc

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 Number697900604CC0018F Basic UDI-DI 06979006042328UDI-DIDate8 Oct 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  • Withdrawn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
Cell culture
Model / Reference
C000035，C000060，C000100，C000035W，C000060W，C000100W，C001035，C001060，C001100，C001035W，C001060W，C001100W，C010001，etc, C000100
Primary DI / UDI-DI
06979006042328
Basic UDI-DI
697900604CC0018F
EMDN Code
W0503040102 Cell and tissue cultures, dishes
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000049623
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No