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Serological Pipettes

by Hangzhou Agen Biotechnology Co Ltd 7 variants

Ref SP03010Model SP01001，SP01002，SP01005，SP01010-1，SP01010-2，SP01025-2，SP01050，SP01100，SP02001，SP02002，SP02005，SP02010-1，SP02010-2，SP02025-2，SP02050，SP02100，SP03005，SP03010，SP03025，SP04010, 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 Number697900604SP001GS Basic UDI-DI 06979006047163UDI-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  • Withdrawn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
Serological Pipettes
Model / Reference
SP01001，SP01002，SP01005，SP01010-1，SP01010-2，SP01025-2，SP01050，SP01100，SP02001，SP02002，SP02005，SP02010-1，SP02010-2，SP02025-2，SP02050，SP02100，SP03005，SP03010，SP03025，SP04010, etc, SP03010
Primary DI / UDI-DI
06979006047163
Basic UDI-DI
697900604SP001GS
EMDN Code
W0503020199 Pipettes - other
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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See all devices from Hangzhou Agen Biotechnology Co Ltd →

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