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Sample Preservation Solution

by Jiangsu Mole Bioscience Co., LTD. 8 variants

Ref PP03010N01T2050

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697089547SPS01VU Basic UDI-DI 06970895470407UDI-DIDate12 Oct 2022RegisteredStatusActive

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  • Withdrawn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
Sample Preservation Solution
Model / Reference
PP03010N01T2050
Primary DI / UDI-DI
06970895470407
Basic UDI-DI
697089547SPS01VU
EMDN Code
W050299 Devices for samples transport - other
Device Class
Class A
EU market of registration
Luxembourg

Manufacturer details

EUDAMED SRN
CN-MF-000001539
Authorised representative
Lotus NL B.V. NL-AR-000000121

Related devices

Category: General specimen container IVD, no additive/medium

Other devices from Jiangsu Mole Bioscience Co., LTD.

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Properties

  • 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