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AmpSure Sample Preservation Solution

by Shanghai Rendu Biotechnology Co., Ltd. China EUDAMED

Ref SPS2-3mL48CEModel SPS2

EMDN W0104010204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697473722SPSSWABHH Basic UDI-DIDate25 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
AmpSure Sample Preservation Solution
Model / Reference
SPS2, SPS2-3mL48CE
Primary DI / UDI-DI
06974737220229
Basic UDI-DI
697473722SPSSWABHH
EMDN Code
W0104010204 Sample transport for na testing
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018869
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai Rendu Biotechnology Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED cc511b2c-4294-4d50-ab6a-1635bf7b94f4 61 fields · synced 24 Oct 2026