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Closed suction systems

by Shaoxing Undis Medical Technology Co., Ltd 81 variants

Part of a family of 92 devices: see the family page

Ref 6Fr（CSS-B06PY）Model XTG

Closed suction systems (6Fr（CSS-B06PY）) is a Class IIa device made by Shaoxing Undis Medical Technology Co., Ltd, registered in EUDAMED on 3 May 2023 (Basic UDI-DI 697053133cssXK), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697053133cssXK Basic UDI-DI 26970531332414UDI-DIDate3 May 2023RegisteredStatusActive EUDAMED: not on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
XTG, 6Fr（CSS-B06PY）
Primary DI / UDI-DI
26970531332414
Basic UDI-DI
697053133cssXK
Direct marketing DI
26970531332414
EMDN code
R050102 Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
Device class
Class IIa
EU registration type
Standard device

Manufacturer details

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

Similar devices in this category

Other devices filed under CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC).

Other devices from Shaoxing Undis Medical Technology Co., Ltd

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

Properties

  • Supplied sterile
Other properties (13, all answered No)