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Closed Suction Systems

by Shaoxing Undis Medical Technology Co., Ltd 81 variants

Ref 10Fr（CSS-B10TY）Model XTG

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number697053133cssXK Basic UDI-DI Date3 May 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
XTG, 10Fr（CSS-B10TY）
Primary DI / UDI-DI
16970531335418, 06970531335411, 16970531335425, 06970531332557, 26970531335422, 26970531335415, 36970531332558, 06970531334216, 26970531334210, 16970531334213, 06970531335428, 26970531332551
Basic UDI-DI
697053133cssXK
Direct Marketing DI
16970531335418
06970531335411
16970531335425
06970531332557
26970531335422
26970531335415
36970531332558
06970531334216
26970531334210
16970531334213
06970531335428
26970531332551
EMDN Code
R050102 Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
Device Class
Class IIa
EU 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

  • 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