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External Drainage and Monitoring Systems

by Tianjin Plastics Research Institute Co., Ltd. 52 variants

Ref 06944803631990Model /

Active European Union

CE MDR

Valid until

13 Nov 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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/MDR Number6944803600110000G3 Basic UDI-DI 06944803631990UDI-DIDate28 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN25/00007713 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    30 Apr 2026
    Expires
    13 Nov 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
External Drainage and Monitoring Systems
Model / Reference
/, 06944803631990
Primary DI / UDI-DI
06944803631990
Basic UDI-DI
6944803600110000G3
EMDN Code
A06010199 Vacuum and gravity drainage systems - other
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000031209
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Tianjin Plastics Research Institute Co., Ltd.

See all devices from Tianjin Plastics Research Institute Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No