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Truclip TCLIP05

by Edwards Lifesciences LLC

Ref TCLIP05

Truclip TCLIP05 is a Class I device made by Edwards Lifesciences LLC, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 0690103D001TRC000Y2) and listed in FDA GUDID since 15 Jul 2025 (UDI-DI 00690103197907), active as of 22 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number0690103D001TRC000Y2 Basic UDI-DI 00690103197907UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103197907 UDI-DI Date15 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001TRC000Y2 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 00690103197907 listed 15 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00690103197907
  2. Registered EUDAMED 0690103D001TRC000Y2

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Truclip
Generic name
Blood pressure transducer holder
Device name
Pressure Monitoring Accessory
Model / Ref / Catalog
TCLIP05
Primary DI / UDI-DI
00690103197907
Basic UDI-DI
0690103D001TRC000Y2
FDA product code
FOX
EMDN code
Z12030299 Vital signs monitoring instruments - other
GMDN term
Blood pressure transducer holder
Device class
Class I
Regulation number
880.6990
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS - OTHER.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)