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Sample Diluent

by Shenzhen Drawray Biotech Co., Ltd. China EUDAMED

Ref DC10009Model A-1: 5mL×2bottles; A-3: 45mL×2bottles; B-1: 5mL×2bottles; B-3: 45mL×2bottles; D-1: 5mL×2bottles; D-3: 120μL×100bottles; D-4: 45mL×2bottles; G-1: 5mL×2bottles; G-3: 45mL×2bottles; H-1: 5mL×2bottles; H-3: 45mL×2bottles

EMDN W01029003

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6973224890043AC Basic UDI-DIDate23 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
Sample Diluent
Model / Reference
A-1: 5mL×2bottles, A-3: 45mL×2bottles, B-1: 5mL×2bottles, B-3: 45mL×2bottles, D-1: 5mL×2bottles, D-3: 120μL×100bottles, D-4: 45mL×2bottles, G-1: 5mL×2bottles, G-3: 45mL×2bottles, H-1: 5mL×2bottles, H-3: 45mL×2bottles, DC10009
Primary DI / UDI-DI
06973224890587
Basic UDI-DI
6973224890043AC
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008763
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Drawray Biotech 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 3dc2938a-6bda-4a42-a0ab-7d8e786e33bd 61 fields · synced 24 Oct 2026