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Clic 050-65-412U

by Flexicare Medical Limited

Ref 050-65-412U

Clic 050-65-412U is a device classified as Class IIa in the EU and Class I in the US made by Flexicare Medical Limited, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-05055931112877) and listed in FDA GUDID since 14 Mar 2024 (UDI-DI 05055931112877), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055931112877 Basic UDI-DI 05055931112877UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055931112877 UDI-DI Date14 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055931112877 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 05055931112877 listed 14 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055931112877
  2. Registered EUDAMED B-05055931112877

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Clic
Generic name
Suction system catheter, general-purpose
Device name
Closed Suction Catheters
Model / reference
050-65-412U
Primary DI / UDI-DI
05055931112877
Basic UDI-DI
B-05055931112877
FDA product code
BSY
EMDN code
R050102 Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
GMDN term
Suction system catheter, general-purpose
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.6810
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Suction system catheter, general-purpose

Similar devices in this category

Other devices filed under RESPIRATORY SUCTION PROBES AND SYSTEMS.

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)