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Disposable specimen collection system

by Weihai Sunway Medical Technology Co., Ltd EUDAMED

Active European Union

Ref QI-7.5.8-02Model Sputum specimen container, Urine specimen container, Sputum specimen tube, Faeces specimen container, Saliva specimen container, Urine Collection tube(white), Urine Collection tube （yellow） No additive, Faeces specimen tube, Saliva specimen tube

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697655656SCS004U7 Basic UDI-DIDate30 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Disposable specimen collection system
Model / Reference
Sputum specimen container, QI-7.5.8-02, Urine specimen container, Sputum specimen tube, Faeces specimen container, Saliva specimen container, Urine Collection tube(white), Urine Collection tube （yellow） No additive, Faeces specimen tube, Saliva specimen tube
Primary DI / UDI-DI
06976556563587, 06976556563518, 06976556563594, 06976556563549, 06976556563563, 06976556563600, 06976556563525, 06976556563556, 06976556563570
Basic UDI-DI
697655656SCS004U7, 697655656SCS001TZ, 697655656SCS009UH, 697655656SCS002U3, 697655656SCS003U5, 697655656SCS010U2, 697655656SCS005U9, 697655656SCS008UF, 697655656SCS007UD
EMDN Code
W05019003, W05010202, W05019001, W05019002
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000025939
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Weihai Sunway Medical Technology Co., Ltd

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Properties

  • Sterile
  • New Device

Other properties (9)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No