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Serological Pipettes

by Hangzhou Agen Biotechnology Co Ltd China EUDAMED

Ref SP01100Model 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

EMDN W0503020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697900604SP001GS Basic UDI-DIDate8 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

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, SP01100
Primary DI / UDI-DI
06979006047064
Basic UDI-DI
697900604SP001GS
EMDN Code
W0503020199 Pipettes - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

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

Other devices from Hangzhou Agen Biotechnology Co Ltd

See all devices from Hangzhou Agen Biotechnology Co Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 70953d6a-fe1e-43ae-a25b-e2d8aff5c555 61 fields · synced 22 Oct 2026