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Closed Suction Systems

by Shaoxing Undis Medical Technology Co., Ltd China EUDAMED

Ref 6Fr(CSS-B06PY)Model XTG EMDN R050102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697053133cssXK Basic UDI-DIDate3 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
XTG, 6Fr(CSS-B06PY)
Primary DI / UDI-DI
36970531332411, 06970531334148, 16970531335142, 26970531335149
Basic UDI-DI
697053133cssXK
Direct Marketing DI
36970531332411
06970531334148
16970531335142
26970531335149
EMDN Code
R050102 Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000002187
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shaoxing Undis Medical Technology Co., Ltd

See all devices from Shaoxing Undis Medical Technology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (4)

  • EUDAMED a7d1808c-1930-494a-aac1-042a73373cf0 61 fields · synced 22 Oct 2026
  • EUDAMED 06970531334148|697053133CSSXK 61 fields · synced 19 May 2026
  • EUDAMED 16970531335142|697053133CSSXK 61 fields · synced 19 May 2026
  • EUDAMED 26970531335149|697053133CSSXK 61 fields · synced 19 May 2026